Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: Sterile Injectable;Broken;Syringe Hub Defect; No additional AE; Complaint Description Detail:  Call to report a product quality complaint (PQC) related to pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE). His customer reported to him that they had two incidences where the glass had broken off of the luer lock on the prefilled syringe when attaching the needle.  Had no further information or pictures. He did provide the customer's contact information and an outbound call was made in an attempt to speak with her. Agent left a message and asked for a call back. Did confirm that no patient's were involved. No AE, no additional PQC.  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 had a line or chip in the glass, but the syringe was essentially intact in one piece. A syringe was considered broken when the syringe is in 2 or more pieces. A syringe was 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: Was there a crack? UNKNOWN BY REPORTER If yes, describe the size, shape & depth of the crack: Provide the exact location of the crack on the syringe:  Was the syringe broken into 2 or more pieces? YES/NO/NA/UNSPECIFIED If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) Provide the exact location of the breakage on the syringe?    Did the syringe have a broken component? YES/NO/NA/UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange): LUER LOCK If yes, describe in detail how it is broken. BROKEN WHEN NEEDLE WAS PLACED ON LUER LOCK. Provide the exact location of the breakage on the syringe? Was the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES/NO/NA/UNSPECIFIED (if yes describe)  Was there difficulty trying to attach the syringe needle to the syringe? UNKNOWN BY REPORTER                    If yes, describe If yes, was it supplied by MERCK: UNKNOWN BY REPORTER If not supplied by MERCK, what type & brand, needle size & gauge was used?' UNKNOWN BY REPORTER  Under what situation was this defect noticed: (select one) UNKNOWN BY REPORTER While the syringe was still in the tray? YES/NO/NA/UNSPECIFIED If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED Is there any broken glass or other separated component in the tray? (if yes specify)  After removing the syringe from the tray? NO  While trying to attach the needle to the syringe? YES While giving the injection? NO  Immediately after giving the injection? NO Was the syringe tip cap attached properly prior to use? UNKNOWN BY REPORTER If no, describe issue:  Was the syringe tray intact and undamaged on receipt? UNKNOWN BY REPORTER  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. UNKNOWN BY REPORTER If no, describe damage  Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNKNOWN BY REPORTER If yes, describe  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? UNKNOWN BY REPORTER  If complaint sample is not/cannot be returned, please provide reason:   If photos were 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. 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:  08-JUL-2022: Second person review performed.  14-JUL-2022 at 15:30 PM: Outbound call 2 of 3 made in attempt to get more information. No answer, message left.  15-JUL-2022 at 17:30 PM: Contacted to follow up with more information on this case. Unfortunately, she did not have much more information than what was originally reported. She did confirm that the luer lock broke off while trying to put the needle on. She does not have the defected syringes for return but says if it happens again, she will keep them and contact. Agent also proactively offered a replacement, but she denied and said she didn't want to do that. No AE. No additional PQC reported.