Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Poor quality device used, Syringe issue
Clinical narrative: No other AE; break of a VAXNEUVANCE syringe following an administration; break of a VAXNEUVANCE syringe following an administration; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not reported.   On 31-JUL-2023, the patient was administered pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number X005583 has been verified to be valid, expiration date reported and established as 10-DEC-2024). Following the administration, the syringe of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) broke (poor quality device used, syringe issue).   No injuries were involved, and no other event was reported (no adverse event).   This case was considered non-valid due to the lack of patient's identifiers.  Staff calling on behalf of another staff from the office that reported experiencing a breakage of a pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (0.5 ml)syringe following an administration of a non-recalled lot. Staff confirmed they are not looking for replacement as product was already administered and disposed of. No injuries involved and staff unable to provide further details. No other AE and no other PQC. **Staff is not looking for replacement as product was administered and disposed of in a SHARPS CONTAINER and unable to send pictures** 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 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. 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? UNSPECIFIED. Nurse calling in regards to another member of the office that had syringe break after administration. Unaware of location or extent of break o If yes, describe the size, shape & depth of the crack: o Provide the exact location of the crack on the syringe: oIs the syringe broken into 2 or more pieces? UNSPECIFIED, Nurse calling in regards to another member of the office that had syringe break after administration. Unaware of location or extent of break o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) o Provide the exact location of the breakage on the syringe? o Does the syringe have a broken component? UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) o If yes, describe in detail how it is broken. o Provide the exact location of the breakage on the syringe? o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? UNSPECIFIED o Was anyone injured as a result of the breakage? NO o If yes, provide brief description of injury o Note to CSR: Report an AE if yes as outlined in Instruction section o Was there difficulty trying to attach the syringe needle to the syringe? NO o If yes, describe o If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED o If not supplied by MERCK, what type & brand, needle size & gauge was used?' o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? NO o If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED o Is there any broken glass or other separated component in the tray? (if yes specify) o After removing the syringe from the tray? NO o While trying to attach the needle to the syringe? NO o While giving the injection? AFTER ADMINISTRATION o Immediately after giving the injection? YES o Was the syringe tip cap attached properly prior to use? YES o If no, describe issue: 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? YES *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)? YES ADMINISTERED AND DISPOSED OF IN A SHARPS CONTAINER. o If complaint sample is not/cannot be returned, please provide reason: Damaged sample already disposed of in SHARPS CONTAINER *If photos are available, ask the customer to send -Not available as product disposed of in sharps container Retrieval Information: o Obtain product (& tray if possible) Not Possible. Staff is not able to return product and is not looking for replacement. 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: 07-AUG-2023: email received with attachment and same attached in record. With the limited information of narrative i.e. "breakage of a pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) syringe following an administration" hence PQC category selected as "Broken syringe-Broken During or After injection". As narrative explains the breakage of syringe after administration and as per table, this is the only one category as best fit for broken syringe after administration, hence added same. Requested, if possible clarify the breakage location of syringe. 07-AUG-2023: Second person review completed. 07-AUG-2023 10:30 AM :Attachment added. 07-AUG-2023 10:30 AM :Email received on 07-AUG-2023 at 5:06 am with the following request from quality: "If possible clarify the breakage location of syringe." See attachment. No AE/PQC. Will forward to case owner for follow up. 07-AUG-2023 14:30 PM :Outbound call attempted at 1:42pm on 07-AUG-2023 to "clarify the breakage location of syringe" based on request from Quality. There was no answer and no voicemail available to leave a message.