Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Syringe issue
Clinical narrative: Sterile Injectable;Broken;Syringe Hub Defect; no adverse event; Complaint Description Detail: Caller was warm conferenced by specialist. Caller reports that a couple days ago (specific date unspecified) that upon opening a carton/box of hepatitis A vaccine, inactivated (VAQTA) pre-filled pediatric syringes there was one syringe that had luer lock end and tip cap that had completely broken off. Caller mentioned that the broken off piece is within the package. However, agent noted that she did not seem 100% certain. Caller reports that this was identified while syringe was still in tray and plastic covering still remains in place. Caller reports that the hepatitis A vaccine, inactivated (VAQTA) was received in good condition, without evidence of damage to the shipping container, box or carton. Caller has not removed the syringe from the package and states she will attempt to provide pictures and set the product and tray aside for retrieval. No further information provided. No adverse events reported. No other product quality complaints. QUESTIONS:  Flip cap dislodged, loose or missing (Medium Risk): - Has the flip cap become dislodged? (i.e. off the vial but found loose inside carton or shipping carton); YES/NO/NA/UNSPECIFIED         - If dislodged, where was the flip cap found?  - Or is it missing? YES/NO/NA/UNSPECIFIED         - If yes, is there evidence on the stopper that it had been punctured by a needle previously? YES/NO/NA/UNSPECIFIED         - If yes, is it possible that someone else in the office removed the flip cap?  - Or it is attached to the vial but loose? YES/NO/NA/UNSPECIFIED  - Is the vial from a single vial carton or a multi-vial carton or tray (10x (ten-by) carton)? (specify)  - If multi-vial carton or tray: How was the carton opened (e.g. using perforation at the thumb notch, opened from the glued end flap side or using a tool? (please specify which)  - If multi-vial carton: What was the location of the affected vial located? Specifically, was it in row closest to the thumb notch or the back row & was it in the middle or the end of the rows? (please be very specific) - How was the product stored? (in or out of the carton)  - Was the vial's carton damaged upon receipt? YES/NO/NA/UNSPECIFIED         - If yes, please describe the appearance of the carton, (e.g. ripped, unglued, crushed).  - Where is the damage to the carton located---please also confirm if the side of the 10x carton with the printed lot/expiry date is damaged?   - From whom was the product obtained/purchased? (e.g. MERCK, wholesaler,):  - Were the contents of the shipper neatly packed or in disarray? (specify which)  - Was the shipping carton/Styrofoam shipper damaged upon receipt?  YES/NO/NA/UNSPECIFIED          - If yes, describe damage in detail: - Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES/NO/NA/UNSPECIFIED    - If complaint sample is not/cannot be returned, please provide reason:  - *If pictures may help, ask the customer to send them  Retrieval Information: Retrieve product.  NOTE: Vaccine vials (MMR-II, PNEUMOVAX 23, VATQA, RECOMBIVAX, GARDASIL/GARDASIL 9, VARIVAX, PROQUAD, PEDVAX,ZOSTAVAX), and Antivenin/Normal horse serum vials that are considered biohazardous may be returned to Merck.  ASSOCIATED ARTICLES SECTION:  - Addl Info Sterile Vial Photo Descriptor - Addl info Product Retrieval Process Guide 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:  03-JUN-2022 14:30 PM :QUESTION SECTION: IF REPORTED:  PQC Prefilled Syringe Cap Fell off or Missing or Loose   (Medium + Risk) - Identify which type of tip cap was used with this syringe: (Plastic Rigid or Rubber) THINK ITS RUBBER - What is the defect: (select one from below)         - Missing? YES         - Loose? (i.e. still on the syringe tip but is either crooked, barely attached or falls off when handled) NA         - If loose, confirm if the Luer Lock/syringe tip is not broken---(if it is broken refer to the appropriate broken syringe article.)          - Dislodged? (i.e. not attached to syringe but in the syringe tray) YES                 - If yes, where was the tip cap found? IN THE PLASTIC SOMEWHERE  - Was the syringe tray intact and undamaged on receipt? YES         - 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. YES         - If no, describe damage  - Was the syringe carton damaged? (i.e. crushed, ripped, unglued) NO         - If yes, describe  - Was the product administered or exposed to patient's bodily fluids(i.e. biohazardous)? NO  - If complaint sample is not/cannot be returned, please provide reason: SAMPLE IS ABLE TO BE RETURNED WITH TRAY   *If photos are available, ask the customer to send them  Retrieval Information: Obtain product (& tray if possible) NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous.  03-JUN-2022 14:30 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 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. - 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).  - Please provide a detailed description of the defect using the questions below:        - Is there a crack? NO                 - If yes, describe the size, shape & depth of the crack: NA                 - Provide the exact location of the crack on the syringe: NA         - Is the syringe broken into 2 or more pieces? YES, SYRINGE PART AND TIP/CAP COMPLETELY BROKEN OFF AND PRESENT IN THE BOX                 - If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) BROKEN OFF, OTHERWISE UNSPECIFIED/UNKNOWN                 - Provide the exact location of the breakage on the syringe? SYRINGE LUER LOCK & TIP/CAP AREA          - Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange)                 - If yes, describe in detail how it is broken. COMPLETELY MISSING/BROKEN OFF                  - Provide the exact location of the breakage on the syringe? SYRINGE LUER LOCK & TIP/CAP AREA                 - Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES (if yes describe) BROKEN OFF          - Was there difficulty trying to attach the syringe needle to the syringe? NA                    - If yes, describe NA                    - If yes, was it supplied by MERCK: NA                    - If not supplied by MERCK, what type & brand, needle size & gauge was used?' NA  - Under what situation was this defect noticed: (select one)         - While the syringe was still in the tray? YES                 - If yes, is there product (liquid or dried residue) in the tray? NOT THAT CALLER COULD TELL                 - Is there any broken glass or other separated component in the tray? (if yes specify) YES BUT FROM JUST THE ONE SYRINGE          - After removing the syringe from the tray? NO, STILL IN TRAY. (TOOK TRAY OUT OF BOX)          - While trying to attach the needle to the syringe? NO           - While giving the injection? NO           - Immediately after giving the injection? NO  - Was the syringe tip cap attached properly prior to use? NA          - If no, describe issue:  - Was the syringe tray intact and undamaged on receipt? YES         - 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. YES         - If no, describe damage  - Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO          - If yes, describe  - Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO  - If complaint sample is not/cannot be returned, please provide reason: SAMPLE WITH TRAY CAN BE RETURNED  *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.  03-JUN-2022 14:30 PM: Attachment added.  03-JUN-2022 14:30 PM: Mail Team please note customer will return one syringe and tray if possible.  03-JUN-2022 14:30 PM: Attachment added.  03-JUN-2022 14:30 PM: Attachment added.  03-JUN-2022 14:30 PM: Email received in the Mailbox on 03JUN2022 at 12:56pm with picture for this report. Picture was embedded in the email so saved separately and added to case. See attachments.  03-JUN-2022: Received & Attached Photos. 03-JUN-2022; Second person reviewed  06-JUN-2022 16:30 PM: Waiting for Retrieval Site from Quality-- See Attachments  06-JUN-2022 16:30 PM: Attachment added.  07-JUN-2022 12:30 PM: Attachment added.  07-JUN-2022 12:30 PM: Email received in the mailbox on 07-JUN-2022 at 8:36am reporting: "The retrieval site." See attachment. Forwarded to the mail team.