Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: NO ADVERSE EVENT; Caller reports 2 broken VAXNEUVANCE PFS, One PFS has leur-lock broken off and the other one has the finger flange broken; She drew medication out of a broken PFS and administered the dose to a patient.; She drew medication out of a broken PFS and administered the dose to a patient.; Caller reports 2 broken pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) PFS.  One PFS had leur-lock broken off and the other one had the finger flange broken.  Caller declined to send pictures. Caller stated, "you can take all the pictures you want once I send them back".  Caller would hold product for return. No adverse event (AE) reported.  No additional Product Quality Complaint (PQC) reported.  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 If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) Broken into several pieces Provide the exact location of the breakage on the syringe?   1 syringe is broken at leur-lock and another syring is broken at finger flange.  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. Leur-lock is off completley - finger flange is broken off. Provide the exact location of the breakage on the syringe? By the leur lock for one syringe and by the finger flange for the other. Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? Yes (if yes describe) broken off of the one syringe.  Was there difficulty trying to attach the syringe needle to the syringe? NA  If yes, describe 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? Yes Is there any broken glass or other separated component in the tray? (if yes specify) yes broken glass in tray.  After removing the syringe from the tray? No  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? Yes 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:  will hold for return  If photos are available, ask the customer to send them, HCP refuses to send photos  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. 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:  19-AUG-2022 15:30 PM: Attachment added.  19-AUG-2022 15:30 PM: Waiting for Retrieval Site from Quality-- See attachments  19-AUG-2022 15:30 PM: Attachment added.  19-AUG-2022 Requested DPOC to confirm with the reporter if the 2 defected syringes are from the same lot.  19-AUG-2022: Second person review performed.  19-AUG-2022 17:30 PM: Attachment added.  19-AUG-2022 17:30 PM: Email received on 19-AUG-2022 at 4:05 pm with the following message from quality: "Can you please confirm with the reporter, if the 2 defected syringes are from the same lot?" See attachment. Will forward to case owner for follow up.  19-AUG-2022 17:30 PM: PQC clarification: Can you please confirm with the reporter, if the 2 defected syringes are from the same lot?  It was confirmed during initial call that both syringes were from the same lot and in the same tray.  19-AUG-2022 17:30 PM: Attachment added.  19-AUG-2022 17:30 PM: Labels created   19-AUG-2022   22-AUG-2022 Based upon further review, has also been added as a lead for the syringe hub defect - broken, as they are the manufacturing site. 22-AUG-2022 The reported and investigative PQC has been updated for the second PFS to Syringe hub defect- broken, since the leur-lock was broken.