Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: the 4th syringe Luer Lock tip did not break off until after the vaccine was administered to the patient; It was reported that the 4th syringe Luer Lock tip did not break off until after the vaccine was administered to the patient and was back in the nurse's hand.; No one was injured; Merck employee called on behalf of a Clinical Coordinator to report an AE/PQC for pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringes. Employee did not have any information regarding AE/PQC other than the provider's office had 4 prefilled pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) syringes that had the Luer Lock tip break off. Employee asked this agent to call the Clinical Lead , the reporter at the doctor's office to get more information about AE/PQC and arrange product replacement. Outbound call made to the reporter, clinical lead, and unable to reach her. Message left with receptionist requesting call back to gather information to file AE/PQC.  Inbound call received from the reporter who was warm transferred by another agent. The reporter, Clinical Lead, reported that within the past 3 weeks they have had a total of 4 pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) syringes that had the Luer Lock tip break off from the prefilled syringe. Three of the syringes Luer Lock tips broke off once the cap was removed while trying to screw on the needle, prior to administration. It was reported that the 4th syringe Luer Lock lip did not break off until after the vaccine was administered to the patient and was back in the nurse's hand. No one was injured. No other information reported by clinical lead who was in a hurry and needed to go take care of patients. AE filed for pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) that was administered to a patient and broke after administering. No injury or harm known to patient or healthcare worker who administered vaccine. PQC filed for other 3 syringes that had the Luer Lock lip break off while attaching the needle. These were not administered to patients. No other information reported. See notes for additional PQC questions.  Clinical Lead who reported stated they do not have the damaged syringes because they threw them away. They also do not have pictures. It was confirmed multiple times that the Clinical Lead could not get the lot numbers and expiration dates of defective syringes so this information is unknown as well as dates administered.  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 ii 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: Provide the exact location of the crack on the syringe:  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.) LUER LOCK TIP OF PRE-FILLED SYRINGE BROKE OFF Provide the exact location of the breakage on the syringe?  Does the syringe have a broken component? YES; DETACHED LUER LOCK (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) If yes, describe in detail how it is broken. LUER LOCK IS BROKEN OFF OF SYRINGES Provide the exact location of the breakage on the syringe? RIGHT AT THE END OF THE LUER LOCK Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES; LUER LOCK IS BROKEN OFF  Was there difficulty trying to attach the syringe needle to the syringe? NO If yes, describe If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED If not supplied by MERCK, what type & brand, needle size & gauge was used?'  Under what situation was this defect noticed: (select one) While the syringe was still in the tray? NO 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? YES  While trying to attach the needle to the syringe? YES (3 SYRINGES)  While giving the injection? NO  Immediately after giving the injection? YES (1 SYRINGE)  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)? YES; ONE BROKE AFTER ADMINISTRATION  If complaint sample is not/cannot be returned, please provide reason: SYRINGES WERE DISCARDED IN BIO HAZARD CONTAINER  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:  17-NOV-2022 18:30 PM: This Case's Nurse was Following-Up with this Case. At current call time, Caller requested being warm transferred to this Case's Original Case Owner at which time Caller was warm transferred to this Case's Original Case Owner. No additional AE/PQC details provided. No additional AE/PQC reported. No further information provided.  17-NOV-2022 18:30 PM :See related CR case# 02288964 for replacement of defective products.  17-NOV-2022 18:30 PM :Attachment added to Service Cloud.  18-NOV-2022: This PR is being investigated with unknown lot number as the units have been discarded and hence the lot numbers and expiration dates of defective syringes cannot be retrieved. Under Product Information, the Search Value of "Unknown pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE)" was not refiecting hence the information provided in Reported Product Description "pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) INJ 0.5 ml 1 DS X 10 SYRINGES' was added for the record progression. Agency will be notified to add the product system.  21-NOV-2022 10:30 AM :Case reopened to create task for mail team  22-NOV-2022: Additional Complaint Category of "Broken During or After injection" was added for the 4th syringe as reported " the 4th syringe Luer Lock tip did not break off until after the vaccine was administered to the patient and was back in the nurse's hand".  22-NOV-2022: Agency  received attached in the reference.  22-NOV-2022: Lead was updated, Agency was removed as lead as per mail attached.  22NOV2022: Second person review completed.  Complaint Description Summary 4 pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) syringes that had the Luer Lock tip break off, 3 of the syringes Luer Lock tips broke off while trying to screw on the needle, prior to administration and the 4th syringe after the vaccine was administered to the patient.