Sex: U
Vaccine: HPV9
Symptoms: Device issue, Poor quality device used, Syringe issue
Clinical narrative: No AE reported; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; glass flange cracked and broke; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Their medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not provided.  On an unspecified date in 2022, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered as prophylaxis, lot number U032636, expiration date 26-OCT-2023  (dosage regimen and route of administration were not provided). When the nurse finished administering the vaccine to the patient the glass flange cracked, broke (poor quality device used/syringe issue). No adverse event reported.  This case was one of several cases from the same reporter.  This was a non-valid report due to lack of patient's identifiers.  Email received on 09-AUG-2022 at 2:40 pm with an attachment reporting 3 PQC' s with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). "1st Incident" filed within this case. All other PQC' s reported within this email handled appropriately. See case notes for more information. Outbound call placed to customer; however, customer did not answer so filing with limited information at this time. It is unknown if the product could be obtained; therefore, the "obtain" box will be left unchecked at this time. Some questions marked "unknown" as they were unable to be asked. HCP demographics were not provided so no letter sent. No AE reported. See attached.  PQC: "1st incident: the glass flange cracked and broke and cut an LVN thumb when she finished the injection. ( still patient, no resistance, normal injection)"  Attachment added.  Sample Tracking Number:  User's Experience: Repeat User  Insertion Difficulty:  Insertion Difficulty Details:  Doubt About Presence:  Doubt Details:  Migration:  Migration Details:  Removal Problem:  Removal Problem Details:  09-AUG-2022 19:30 PM: QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC:  A cracked syringe had a line or chip in the glass, but the syringe was essentially intact in one piece. A syringe is considered broken when the syringe was in 2 or more pieces.  A syringe was also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaked into 2 or more pieces during use (such as while attaching a needle or injecting diluent). Please provide a detailed description of the defect using the questions below:  was there a crack? YES  o~If yes, describe the size, shape and depth of the crack: UNKNOWN o~Provide the exact location of the crack on the syringe: UNKNOWN was the syringe broken into 2 or more pieces? UNKNOWN  If yes, describe in detail how it was broken: (e.g. shattered, broken in half etc.) UNKNOWN  Provide the exact location of the breakage on the syringe? UNKNOWN Did the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) o~If yes, describe in detail how it was broken. UNKNOWN o~Provide the exact location of the breakage on the syringe? "GLASS FLANGE" o~was the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? UNKNOWN (if yes describe) o~Was there difficulty trying to attach the syringe needle to the syringe? UNKNOWN o~If yes, describe UNKNOWN o~If yes, was it supplied by MERCK: UNKNOWN If not supplied by MERCK, what type & brand, needle size & gauge was used? UNKNOWN Under what situation was this defect noticed: (select one) AFTER ADMINISTRATION  o~While the syringe was still in the tray? NO o~If yes, is there product (liquid or dried residue) in the tray? NA o~Is there any broken glass or other separated component in the tray? (if yes specify) NA o~After removing the syringe from the tray? NO While trying to attach the needle to the syringe?NO o~While giving the injection? NO o~Immediately after giving the injection? YES Was the syringe tip cap attached properly prior to use? UNKNOWN  If no describe issue: Was the syringe tray intact and undamaged on receipt? UNKNOWN  If no, describe damage. If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. UNKNOWN  If no, describe damage Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) UNKNOWN  If yes, describe Was the product administered or exposed to patient' s bodily fluids (i.e. biohazardous)? YES If complaint sample was not/could not be returned, please provide reason: UNKNOWN IF THE PRODUCT CAN BE OBTAINED AT THIS TIME. OUTBOUND CALL PLACED TO CUSTOMER AND VOICEMAIL LEFT REQUESTING A CALLBACK.  *If photos are available, ask the customer to send them Retrieval Information:  Obtain product (& tray if possible)  Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite.  NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous.  09-AUG-2022 19:30 PM :Case 02060951 = Original HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) PQC reported; Case 02151379 = Pneumococcal Vaccine, Polyvalent (23-valent) PQC mentioned in attached email chain on 18-APR-2022 at 3:43pm; Case 02151454 = Miscellaneous product mentioned in attached emai 1 chain on 18-APR-2022 at 3: 43pm; Case 02222329 = Incident 1 PQC reported in word documented attached to email; Case 02222255 = Incident 2 PQC reported in word documented attached to email; Case 02222256 = Incident 3 PQC reported in word documented attached to email.  09-AUG-2022 19: 31 PM : Outbound call placed to customer. Voicemai 1 left with phone number and case number. All PQC details need to be collected from customer as limited information was provided within the emai 1. 09-AUG-2022 19:31 PM :Outbound call placed. He reported that he has no additional information and to contact then reporter. Saw below note where outbound call was placed to the reporter 10-AUG-2022: Reported lot U032636 logged under 368084 & 2nd incident from unknown lot logged under 368085  10-AUG-2022; Second person reviewed. 10-AUG-2022: email containing correspondence and PHOTOS received & attached  10-AUG-2022: Requested clarify word document attachment  dated 09-AUG-2022 - for photos provided in this email what case do they correspond with and can lot numbers be obtained for images in pages 4,5,6 and 7.  11-AUG-2022: Based on photo provided by the reporter where lot 1780878 was observed, this record was updated to reflect lot 1780878 and place was removed as Lead, Manufacturing & Packaging Sites  11-AUG-2022: Requested confirm if there are two syringes or if the two photos are from the same syringe from lot 1780878 based on photos provided by reporter.  11-AUG-2022; Second person reviewed  11-AUG-2022 12:30 PM :Attachment added. 11-AUG-2022 12:30 PM :Email received on 11-AUG-2022 at 11:14am with the following request from Quality: "Appears in the photos provided by the reporter that there are two broken syringes from lot 1780878. Please confirm if there are two syringes or if the two photos are from the same syringe." See attached. Forwarded to case owner for follow up. 11-AUG-2022 12:30 PM :The photos provided correspond to case 02222256 and are not associated with this case. The customer has not been able to be reached at this time; therefore, no further clarification has been received. Will update case notes when the customer has been contacted. 11-AUG-2022 12:30 PM;Attached f/u: 2nd Outbound call placed to customer. Voicemail left with phone number and Interaction number for all relevant cases. When customer called back, all PQC details woild be collected. Until contact is made with the customer, no further information is available. 15-AUG-2022 15:30 PM :3rd Outbound call placed to customer. Voicemail left with phone number and Interaction number for all relevant cases. When customer calls back, all PQC details will be collected. Until contact is made with the customer, no further information is available. 15-AUG-2022 16: 30 PM : Inbound call received from customer. The customer reports that this incident was reported to his coordinator. The customer reports the lot/expiration date for the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as U032636 26-OCT-2023. He reports that the nurse who cut her thumb had some swelling of the thumb. She reached out to her physician for evaluation. The thumb was cleaned and first aid was provided. The thumb is now healed. The customer reports that this is the only information he has on the incident and declines further contact. He reports that the product was discarded in a sharps container and is not available to return. He reports that he received this information second hand and cannot provide any additional information or answer any other questions.16Aug2022: Based on confirmation received from the customer the Reported Lot Number and Lot Number fields were updated to U032636 and the Lead.  16-AUG-2022: Lot 178078 logged under 368084 & unknown logged under 368085  16-AUG-2022: Information entered in the Batch tab, Batch Details, Batch by were removed.  16-AUG-2022; Second person reviewed  16-AUG-2022 13:30 PM :Update applied, refer 16-AUG-2022:  Requested obtain product if possible.  17-AUG-2022:  - Packaging Site was updated.  17-AUG-2022; Second person reviewed. ; Sender's Comments:  US-009507513-2208USA004763: US-009507513-2111USA008646: US-009507513-2111USA009249: US-009507513-2204USA007742: US-009507513-2208USA004763: