Sex: U
Vaccine: PNC15, PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: Nurse's Facility had 'received recent shipment of VAXNEUVANCE which had contained 2 broken syringes upon shipment delivery' with Both Corresponding VAXNEUVANCE Prefilled Syringes; Caller was unable confirm if Corresponding Multiple, Unknown, Separate Patients, 'in Setting,' were ever administered Affected VAXNEUVANCE; NO AE reported/ Uninjured; Complaint Description Detail  Caller was Merck Field Employee who was calling on Behalf of Nurse. Caller, on Nurse's Behalf, reported AE/PQC for Multiple, Unknown Separate Patients.  At current call time, Caller was unable confirm if Corresponding Multiple, Unknown, Separate Patients, 'in Setting,' were ever administered Affected pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) via Corresponding pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe prior to or at current call time. As confirmed by Caller at current call time, Nurse's Facility had 'received recent shipment of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) which had contained 2 broken syringes upon shipment delivery' with Both Corresponding pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringes having presented with a broken glass circular piece near back of syringe. Caller was unable to Answer this Case's PQC Questions which are located within this Case's Attached Note since Caller had limited information which was obtained secondhand via this Case's Nurse. Caller was unable to further clarify these statements at current call time.   Caller had limited information at current call time. As confirmed by Caller at current call time, Caller had expressed intent on having this Case's Nurse send this Case's Affected Product Pictures via E-Mail to E-Mail. As confirmed by Caller at current call time, the '1st' Corresponding Affected pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe was available for return, and the '2nd' Corresponding Affected pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe was discarded on unknown date / not available for return. No AE reported. No additional PQC reported. No further information provided.  QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for agency:  Customer Feedback Reported: At current call time, Caller made general statement / mentioned how 'broken pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringes' was a 'huge problem across the country.'  16-FEB-2023 04:30:1. When recording feedback, record the appropriate customer feedback category in the Notes section using the following categories: Availability, Cost, Label Content & Artwork, Miscellaneous, Packaging, Product Feedback 16-FEB-2023 04:30: Per Management Guidance and on Outbound Call, a 1st Attempt was made to contact this Case's Nurse to obtain Answers to this Case's PQC Questions. At current call time and on warm transfer from Unknown Healthcare Professional, this Case's Nurse was able to provide Answers to this Case's PQC Questions which are located within following space. At current call time, Caller had confirmed how this Case's previously Unopened, Sealed, Undamaged Affected Products' Shipment was received on unknown date with Corresponding Affected Products' Cartons having previously been Sealed, Unopened, Undamaged prior to Unknown, Healthcare Professional having opened Corresponding Affected Products' Cartons.  Specific to '1st' Corresponding pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe and upon opening Corresponding Carton, this Case's Nurse had confirmed how this Case's '1st' Corresponding Affected VANEUVANCE Prefilled Syringe's 'glass circular piece near back of syringe' / 'finger flange' was already broken off of Corresponding Affected Product with Corresponding Affected Product's 'finger flange sliding back and forth on plunger' and with 'broken pieces of glass in tray.' As confirmed by Caller at current call time, this Case's '1st' Corresponding Affected pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe was never administered to any Patient prior to or at current call time. At current call time, Caller was unable to confirm if Corresponding, Intended Patient had missed pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Dose prior to or at current call time.  Specific to '2nd' Corresponding pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe and upon opening Corresponding Carton, this Case's Nurse had confirmed how this Case's '2nd' Corresponding Affected pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe's 'glass circular piece near back of syringe' / 'finger flange' had 'broke while pushing into arm of this Case's Separate, Unknown Patient by Unknown Medical Assistant with Corresponding Affected Product's 'finger flange sliding back and forth on plunger' at event time. As confirmed by this Case's Nurse at current call time, Corresponding Medical Assistant was never exposed to corresponding Affected Product with corresponding Affected Product having never leaked prior to or at current call time. As confirmed by this Case's Nurse at current call time, both Corresponding Medical Assistant and Corresponding, Separate, Unknown Patient were unaffected by event and had remained uninjured prior to and at current call time. As confirmed by this Case's Nurse at current call time, the '1st' Corresponding Affected pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe was available for return, and the '2nd' Corresponding Affected pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe was discarded on unknown date / not available for return. As confirmed by this Case's Nurse at current call time, this Case's Nurse had expressed intent on sending this Case's Affected Product Pictures via E-Mail to E-Mail on unknown, future date. No additional AE/PQC reported. No further information provided.  Is there a crack? NO Is the syringe broken into 2 or more pieces? YES Does the syringe have a broken component? YES  Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO Was there difficulty trying to attach the syringe needle to the syringe? NO  While the syringe was still in the tray? YES If yes, is there product (liquid or dried residue) in the tray? NO After removing the syringe from the tray? YES While trying to attach the needle to the syringe? NO While giving the injection? YES Immediately after giving the injection? NO Was the syringe tray intact and undamaged on receipt? YES If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO 16-FEB-2023 04:30: Attachment added to system. 16-FEB-2023 04:30: Attachment added to system. 16-FEB-2023 04:30: AE Adverse Experience Missed Dose Misuse was meant to be attached to this Case. No additional AE/PQC reported. No further information provided. 16FEB2023 : As per the information provided in narrative, 2 complaint category have been assigned for 2 syringes as below: First syringe: Complaint Category selected as: "Broken Syringe >> N/A >> Secondary Packaging": was assigned as complainant stated that upon opening carton, this Case's Nurse had confirmed 1st' affected pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe's 'glass circular piece near back of syringe' / 'finger flange' was already broken off. Second Syringe: Complaint Category selected as: Broken Syringe >> Broken During or After injection >> Primary Packaging" was assigned as complainant stated that upon opening carton 2nd affected pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringe's  agency was notified to provide the Images of the complaint sample. 16FEB2023: : Second person review completed. 16-FEB-2023 10:30: Attachment added to system. 16-FEB-2023 10:30: Upon Case Reopening, Article was added to this Case. No additional AE/PQC reported. No further information provided. 16-FEB-2023 10:30: Case Detail Clarification: Case Details were meant to be read as follows: No additional AE/PQC reported. No further information provided. 16-FEB-2023 10:30: Attachment added to system. 16-FEB-2023 10:30: Email received in the PQC Mailbox on 16-FEB-2023 at 07:49 from quality with the following request: "Dear agency, Acknowledged receipt of this PQC. Kindly provide images of complaint sample Confirm if both the syringes have same lot number-W021510." See attached. Email forwarded to case owner for further handling. 16-FEB-2023 11:30: In response to Quality Prompt per Attached Quality E-Mail and per Management Guidance, Answers to Quality Prompted Questions were provided at time of this Case's original Outbound Call to this Case's Nurse with Quality Prompted Question Detail Summary located within following space. No additional AE/PQC reported. No further information provided. 1.) Acknowledged receipt of this PQC. Both this Case's Merck Field Employee at original call time and this Case's Nurse at original Outbound Callback Time were made aware how information from this Case would be forwarded to Quality. 2.) Kindly provide images of complaint sample: At time of Original Outbound Call to Nurse and as confirmed by this Case's Nurse per this Case's Original Outbound Call Note, this Case's Nurse had expressed intent on sending this Case's Affected Product Pictures to E-Mail on unknown, future date. 3.) Confirm if both the syringes have same lot number-W021510: Per this Case's Product's Section: the 2 Corresponding pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringes from this Case were from the same Lot#/Expiry: Lot#: W021510; Expiry: 10/08/2023. 16-FEB-2023 16:30: Attachment added to system. 16-FEB-2023 16:30: Email received in Contact Center Mailbox on 16FEB2023 at 14:00 from the field representative: "See below for picture of broken pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Pediatric syringe. Please note, it appears there was an error attaching the picture in the email as it is not visible. Forwarding to case owner for follow up. 16-FEB-2023 17:30 PM :Follow-Up Guidance: Upon this Case's Nurse's Inbound Follow-Up on Callback, please reconfirm Answers to this Case's Quality Prompted Questions: This Case's Quality Prompted Question Detail Summary is located within following space. In response to this Case's most recently Attached E-Mail and per Management Guidance, a 1st Attempt was made to contact this Case's Nurse to reconfirm Answers to this Case's Quality Prompted Questions. At current call time and on warm transfer from Unknown Healthcare Professional, Voicemail was left for this Case's Nurse containing this Case# and the Phone#.  No additional AE/PQC reported. No further information provided. This Case's Quality Prompted Question Detail Summary: 1.) Kindly provide images of complaint sample since, according to Most Recently Attached E-Mail, 'It appears there was an error in attaching the picture in the email as it is not visible:' 2.) Please Reconfirm if both the syringes have same lot number-W021510: (Acknowledged receipt of this PQC: Both this Case's Merck Field Employee at original call time and this Case's Nurse at original Outbound Callback Time were made aware how information from this Case would be forwarded to Quality) 17-FEB-2023 24:36: Waiting Retrieval site from Quality -- see attachment 17FEB2023 : Below were Interface updates received: 1) As confirmed by agency, the 2 Corresponding pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Prefilled Syringes from this Case were from the same Lot#/Expiry: Lot#: W021510; Expiry: 10/08/2023. 2) Email received in Contact Center Mailbox on 16FEB2023 from the field representative: "See below for picture of broken pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Pediatric syringe. See attached, but it appears there was an error attaching the picture in the email as it is not visible. 3) 1st Attempt was made to contact this Case's Nurse to collect above requested information agency notified regarding the above information. 17-FEB-2023 11:30: Attachment added to system. 17-FEB-2023 11:30: Retrieval site is at agency. 17-FEB-2023 11:30: Labels Created for agency. Shipped on 2/17/2023. Outbound Tracking # - Return Tracking #  18-FEB-2023 : agency notified to send sample to agency. Mail attached. 17-FEB-2023 15:30: Inbound call received from nurse, who stated she is just returning a voicemail that was left requesting a call back for this case. She stated she thinks it may be an old voicemail since she has already called back and spoke with an agent and answered all needed questions related to AE/PQC. Nurse was informed that this agent did not see any additional information needed at this time and informed her that the replacement was approved and return mailer was sent today. No additional AE/PQC reported. 17-FEB-2023 17:30: In response to this Case's most recently Attached E-Mail and per Management Guidance, a 2nd Attempt was made to contact this Case's Nurse to reconfirm Answers to this Case's Quality Prompted Questions. At current call time and on warm transfer from Unknown Healthcare Professional, this Case's Nurse was able to reconfirm Answers to this Case's Quality Prompted Questions: This Case's Quality Prompted Question Detail Summary is located within following space. No additional AE/PQC reported. No further information provided. This Case's Quality Prompted Question Detail Summary 1.) Kindly provide images of complaint sample since, according to Most Recently Attached E-Mail, 'It appears there was an error in attaching the picture in the email as it is not visible:' AS CONFIRMED BY THIS CASE'S NURSE AT CURRENT CALL TIME, CALLER, DURING CALL, HAD SENT AFFECTED PRODUCT PICTURES VIA E-MAIL TO E-MAIL. 2.) Please Reconfirm if both the syringes have same lot number-W021510: AS RECONFIRMED BY THIS CASE'S NURSE AT CURRENT CALL TIME, THIS CASE'S 2 CORRESPONDING AFFECTED pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) PREFILLED SYRINGES WERE BOTH FROM LOT#/EXPIRY: LOT#: W021510; EXPIRY: 10/08/2023. (Acknowledged receipt of this PQC: Both this Case's Merck Field Employee at original call time and this Case's Nurse at original Outbound Callback Time were made aware how information from this Case would be forwarded to Quality) 17-FEB-2023 17:30: Attachment added to system. 17-FEB-2023 17:30: Email received in the mailbox on 17-FEB-2023 at 15:52 with pictures associated with this case. See attachment.