Sex: U
Vaccine: PNC15, PNC15
Symptoms: Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;Broken;Syringe Hub Defect; the medication was leaked into the carton; Medical Assistant called stating they received an order of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (10 count) which they order through their Merck Representative. When initially opening the shipment and prior to removing vaccines from carton, it was found that 2 of the 10 prefilled syringes were broken and the medication was leaked into the carton. Caller states that the needle hub tip of the pre-filled syringe was completely broken off of 2 syringes and loose in the carton. Caller stated that there appeared to be no damage to the cellophane wrap, the carton or the box they arrived in. The 2 syringes were found broken prior to removing them from the carton. No patient's involved. No AE reported. PQC filed.   Caller requested replacement and sent pictures which are attached to case. Caller stated their was no rush on replacement and will hold onto the broken syringes and carton to return to Merck. Reemphasized to caller to only return the damaged products and the carton and to keep the undamaged products.  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 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:                 o Provide the exact location of the crack on the syringe:         o Is the syringe broken into 2 or more pieces? YES                 o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) THE TIP WHERE THE NEEDLE IS PLACED IS COMPLETELY SNAPPED OFF                 o Provide the exact location of the breakage on the syringe? NEEDLE HUB WHERE NEEDLE ATTACHES TO 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. NEEDLE HUB IS COMPLETELY BROKEN/SNAPPED OFF                 o Provide the exact location of the breakage on the syringe? NEEDLE HUB WHERE NEEDLE ATTACHES                 o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES (if yes describe) COMPLETELY BROKEN OFF          o Was there difficulty trying to attach the syringe needle to the syringe? N/A. WE NEVER TRIED TO ATTACH A NEEDLE BECAUSE IT WAS COMPLETELY BROKEN OFF AND MOST OF LIQUID LEAKED OUT                    o If yes, describe                    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? YES                 o Is there any broken glass or other separated component in the tray? (if yes specify) YES; BROKEN NEEDLE HUB OF SYRINGE LOOSE IN THE TRAY          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? NO          o If no, describe issue: NEVER USED  o Was the syringe tray intact and undamaged on receipt? YES         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. YES         o If no, describe damage  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: N/A  *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: Repeat User Insertion Difficulty:  Insertion Difficulty Details:  Doubt About Presence:  Doubt Details:  Migration:  Migration Details:   Removal Problem:   Removal Problem Details:  04-AUG-2022 17:30: Attachment added.  04-AUG-2022 17:30: Email received in the mailbox on 04-AUG-2022 at 15:04 with pictures associated with this case. See attachment.  04-AUG-2022 17:30: Attachment added.  04-AUG-2022 17:30: Attachment added.  04-AUG-2022: reviewer A; Attached PHOTO and AE Correspondence.  05-AUG-2022: Second person review performed by reviewer B.  05-AUG-2022 14:30: Waiting for Retrieval Site from Quality-- See attachments  05-AUG-2022 14:30: Attachment added.  05-AUG-2022 15:30: Attachment added.  05-AUG-2022 15:30:  05-AUG-2022   10-AUG-2022; reviewer A; Patient code was changed to correct field; "No Health Consequence or Impact; C50675; F26 (Medical Device Reportable PQC).  10-AUG-2022: Second person review performed by reviewer B  10-AUG-2022; reviewer A; Updated Medical Device Reporting Rationale to "Based on the Reportability Matrix for this Product, a Reportability Assessment is needed."  10-AUG-2022: Second person review performed by reviewer B  10-AUG-2022 17:30: Attachment added.  10-AUG-2022 17:30: Email received in the Mailbox on 10-AUG-2022 at 16:09 reporting the mailer was received. Product return date updated and case closed. See attachment.