Sex: U
Vaccine: HEPA
Symptoms: Syringe issue
Clinical narrative: Sterile Injectable;N/A;Broken Syringe; No advese event; New PQC created for VAQTA syringe returned with lot U004366. Product arrived "broken" at the flange (please see attachments in case 02254862 for pictures of non labeled syringe). No additional PQC details or PQC. FROM CASE 02254862. THIS SYRINGE WAS RETURNED WITH ANOTHER BROKEN SYRINGE. CUSTOMER WILL BE CONTACTED FOR ANY ADDITIONAL INFORMATION.   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 has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. o A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears 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 Is there a crack? NO o If yes, describe the size, shape & depth of the crack: NA o Provide the exact location of the crack on the syringe: NA  o Is the syringe broken into 2 or more pieces? YES o If yes, describe in detail how it is broken: "The part where you put your fingers on is broken off the rest of the syringe" o Provide the exact location of the breakage on the syringe? "top portion, where your fingers rest on the syringe"  o Does 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. "The part where you put your fingers on is broken off the rest of the syringe" o Provide the exact location of the breakage on the syringe? "top portion, where your fingers rest on the syringe" o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO o Was there difficulty trying to attach the syringe needle to the syringe? N/A o If yes, describe N/A o If yes, was it supplied by MERCK: N/A o If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A  o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? YES o If yes, is there product (liquid or dried residue) in the tray? NO o Is there any broken glass or other separated component in the tray? Unknown by reporter  o After removing the syringe from the tray? N/A  o While trying to attach the needle to the syringe? N/A  o While giving the injection? N/A  o Immediately after giving the injection? N/A  o Was the syringe tip cap attached properly prior to use? N/A o If no, describe issue: N/A  o Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. n/A  o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. Unknown by Reporter o If no, describe damage N/A  o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO  o If complaint sample is not/cannot be returned, please provide reason:  *If photos are available, ask the customer to send them  Retrieval Information: o Obtain product (& tray if possible) o 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. Sample Tracking Number:  User's Experience: Unknown Insertion Difficulty:  Insertion Difficulty Details:  Doubt About Presence:  Doubt Details:  Migration:  Migration Details:   Removal Problem:   Removal Problem Details:  19-OCT-2022 13:30 PM :Outbound call placed to customer for quality clarification from case 02254862: "Can you please follow up with the reporter today as this is a High Risk reportable PQC that needs clarification. The customer returned two broken syringes. One syringe was unlabeled and the other syringe was from lot# U004366. We were expecting two syringes from lot W002889, however the second syringe was from Lot U004366. Please confirm if there is still a PQC of two broken syringes and a label missing PQC against initially reported lot W002889 (captured in # 2209USA011225). Is the returned syringe with lot U004366 a third syringe they received with broken syringe issue? In total, how many syringes were reported with a PQC?"  Voicemail left with phone number, hours of operation, and case number. Upon callback, please clarify above information for quality. Thanks.  19-OCT-2022 13:30 PM :Please see case notes in case 02254862 for follow up regarding this case. Customer did confirm 2 separate products were involved. No additional PQC details or AE.  19-OCT-2022;  Date of Company Awareness has been changed to 10-OCT-2022;  based on the date the additional sample was returned.  19-OCT-2022, second person review.  21-OCT-2022; Based on the Date of Company Awareness being 10-OCT-2022 due to sample returned, the Date Due has been updated to 09-NOV-2022 ; Sender's Comments:  US-009507513-2209USA011225: