Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;N/A;Broken Syringe; Complaint Description Detail Email received in the Mailbox 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). "3rd 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 was unknown if the product can 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: "3rd incident: Happened yesterday Monday 18-AUG-2022. In a box of 10 one of the glass flanges was broken for 1 syringe, all others were intact." Pictures within the attached email are referencing this case. 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:  o A cracked syringe had a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe was considered broken when the syringe is in 2 or more pieces. o A syringe was also considered "cracked" if it appeared to be intact with evidence of a chip or crack OR appeared to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent). o Please provide a detailed description of the defect using the questions below: o Was there a crack? UNKNOWN o If yes, describe the size, shape & depth of the crack: UNKNOWN o Provide the exact location of the crack on the syringe: UNKNOWN o Was the syringe broken into 2 or more pieces? UNKNOWN o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) UNKNOWN o Provide the exact location of the breakage on the syringe?  UNKNOWN o 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 is 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 o If not supplied by MERCK, what type & brand, needle size & gauge was used?' UNKNOWN o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? UNKNOWN o If yes, was there product (liquid or dried residue) in the tray? UNKNOWN o Was there any broken glass or other separated component in the tray? (if yes specify) UNKNOWN o After removing the syringe from the tray? UNKNOWN o While trying to attach the needle to the syringe? UNKNOWN o While giving the injection? UNKNOWN o Immediately after giving the injection? UNKNOWN o Was the syringe tip cap attached properly prior to use? UNKNOWN o If no, describe issue: o Was the syringe tray intact and undamaged on receipt? UNKNOWN o If no, describe damage. o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  *See below. UNKNOWN o If no, describe damage o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNKNOWN o If yes, describe o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? UNKNOWN o If complaint sample is not/cannot be returned, please provide reason: UNKNOWN IF PRODUCT CAN BE OBTAINED. OUTBOUND CALL PLACED TO CUSTOMER AND VOICEMAIL LEFT REQUESTING A CALLBACK.  *If photos are available, ask the customer to send them PHOTOS ATTACHED TO CASE  Retrieval Information:  o Obtain product (& tray if possible) o Expedite return for cracked syringes. If there is a doubt whether it was 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)(PNEUMOVAX 23) PQC mentioned in attached email chain on 18-APR-2022 at 3:43pm; Case 02151454 = Miscellaneous product mentioned in attached email 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 19:30 PM: Outbound call placed to customer. Voicemail left with phone number and case number. All PQC details need to be collected from customer as limited information was provided within the email.  09-AUG-2022 19:30 PM: Outbound call placed. They reported that they had no additional information and to contact other. See below note where outbound call was placed.  10-AUG-2022;  Second person reviewed.  10-AUG-2022: Unknown lot from 3rd incident logged under 368086 & Unknown log from 2nd incident logged under 368085  10-AUG-2022: email containing correspondence and PHOTOS received & attached  10-AUG-2022: Requested clarify word document attachment. Good dated 09-AUG-2022 - for photos provided in this email what case did they correspond with and can lot numbers be obtained for images in pages 4,5,6 and 7.  11-AUG-2022 11:30 AM: Attachment added.  11-AUG-2022 11:30 AM: Email received in the Mailbox on 10-AUG-2022 at 6:14pm from quality stating: "Clarification requested on word document attachment. Good 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." See attached. Email forwarded to case owner for follow up.  11-AUG-2022 11:30 AM: Pictures from the word document attachment correspond to this case, 02222256 as written in the description of the case. The lot number was obtained from the image of the box on page 2 and documented within case 02222256. Based on the picture on page 5 the lot number/expiration directly on the syringe appears to read as: 1780878 02-DEC-2023.  11-AUG-2022: Requested confirm if there were two syringes or if the two photos were from the same syringe from lot 1780878 based on photos provided by reporter.  12-AUG-2022; Attached f/u:  2nd Outbound call placed to customer. Voicemail left with phone number and Interaction number for all relevant cases. When customer calls back, all PQC details would be collected. Until contact was made with the customer, no further information was 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 was available.  15-AUG-2022 16:30 PM: Inbound call received from customer. The customer reported that this incident was already reported to his coordinator. It was reported to him that when a box of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringes were initially opened, it was noted that one of the syringes was broken. He did not know if the primary box was damaged as he reported that he did not unpackage the products. He reported that this was the only information he had on the incident and declined further contact. He reported that the product was discarded and was not available to return. He reported that he received this information second hand and could not provide any additional information or answer any other questions.  This is one of several reports from the same source. ; Sender's Comments:  US-009507513-2111USA009249: