Sex: U
Vaccine: PNC15
Symptoms: Skin laceration, Syringe issue
Clinical narrative: no adverse event; patient was vaccinated / syringe broke at the finger flange /  patient was able to receive the full dose; syringe broken; This spontaneous report was received from a medical assistant referring a patient of unknown age and gender.   The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 18-DEC-2023, the patient was vaccinated with single dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (lot#: X020316, expiration date: 18-OCT-2025; strength, dose, and route of administration were not reported) for prophylaxis, the syringe broke (syringe broken) at the finger flange  while it was being administered. The reporter stated that the patient was able to receive the full dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (Poor quality device used) and no adverse event was experienced. It was reported that there was no crack noted on the syringe.   This is one of two cases from the same reporter. This case was considered non-valid due to lack of patient identifiers.   Complaint Description Detail 19-DEC-2023: Based on the number of occurrence and lot trending for the product pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE), this is the 3rd complaint (PR#396810, PR#401762 and PR #402394) each reported with Lot number X020316 for the PQC category 'Broken Syringe'. As the said product family is not available in Lot Threshold Table for the said defect, a default Action Limit for the reported complaint is considered as '3' and the lot level trend number does exceed the action limit. Hence, the priority for the reported case will be 'High Risk'. HCP called to report that 2 syringes of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) with the same lot number and expiration date have broken off at the sight of the finger flange. HCP reports that SYRINGE 1 was broken on an unspecified date, sometime last week. HCP reports that SYRINGE 1 was discovered broken in 2 pieces at the sight of the finger flange, while it was still in the tray. HCP reports that SRYINGE 1 was not used on a patient, and was disposed of, and therefore unavailable for photos or retrieval. HCP reports that SYINGE 2 broke while administering a single dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE to a patient, today, 18-DEC-2023. HCP reports that the syringe broke at the sight of the finger flange, and a piece of glass broke off the syringe "slicing" the HCP's middle finger. HCP reports that the patient was able to receive the full dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) HCP reports that she sustained a small laceration to the middle finger that she was able to clean out and bandage herself. HCP did not need to seek medical attention. HCP reports that the SYRINGE 2 is available for retrieval. HCP is forwarding photos of SYRINGE 2. HCP gives permission to contact. HCP has no further AE/PQC information. See CR case 02524290. See additional AE case for the patient who received the administered dose: 02524374. HCP did not give her physicians information. HCP did give permission to contact herself and therefore HCP sent the consumer request to contact HCP letter. No further AE/PQC information is available at this time. 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? HCP reports that no crack was noted on either broken syringe. If yes, describe the size, shape & depth of the crack: N/A Provide the exact location of the crack on the syringe: N/A Is the syringe broken into 2 or more pieces? yes, hcp reports that both syringes were broken in the same way. hcp reports that the 1st syringe was discovered broken at the sight of the finger flange, upon opening the packaging, on an unspecified date last week. hcp reports the seoncd sryinge was broken at the exact same point of the syringe, the finger flange. hcp reports that second syringe broke while administering the dose to the patient. If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) BOTH SYINGE ONE AND TWO ARE BROKEN INTO 2 OR MORE PIECES. Provide the exact location of the breakage on the syringe? BOTH SYRINGE ONE AND TWO BROKE AT THE SIGHT OF THE FINGER FLANGE Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) FINGER FLANGE  If yes, describe in detail how it is broken. THE FINGER FLANGE OF SYRINGE ONE AND TWO BROKE ENTIRELY OFF THE SYRINGE. Provide the exact location of the breakage on the syringe? THE FINGER FLANGE OF BOTH SYRINGE ONE AND SYRINGE TWO. Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO (if yes describe) Was anyone injured as a result of the breakage? YES If yes, provide brief description of injury: hcp reports that she sustained a small slice from the broken glass of the finger flange on her interior of her middle finger. hcp reports that she was able to clean and banage the cut without assistance, and that no further treatment is needed for he injury. Note to CSR: Report an AE if yes as outlined in Instruction section Was there difficulty trying to attach the syringe needle to the syringe? NO If yes, describe N/A If yes, was it supplied by MERCK: N/A If not supplied by MERCK, what type & brand, needle size & gauge was used? N/A Under what situation was this defect noticed: (select one) While the syringe was still in the tray? yes - this was how the first syringe was noted If yes, is there product (liquid or dried residue) in the tray? hcp does not recall if there was any product in the tray Is there any broken glass or other separated component in the tray? (if yes specify) yes, the tray contained The broken pieces of the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) syringe. After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While giving the injection? yes, the seconds syinge broke while it was being administered to a patient. patient recieved the full dose. Immediately after giving the injection? NO Was the syringe tip cap attached properly prior to use? YES If no, describe issue: N/A Was the syringe tray intact and undamaged on receipt? YES If no, describe damage. N/A 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 N/A Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) no damage noted by hcp If yes, describe Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES If complaint sample is not/cannot be returned, please provide reason: hcp was able to save the second syringe that was adminsitered to a patient, and caused injury to the hcp for retieveal. the frist sryinge that was discovered in the tray was disposed of and is unavailable for retrieval. If photos are available, ask the customer to send them to company email account HCP IS sending photos of the second sryinge that was adminsitered to a patient, and caused injury to the hcp. hcp does not have photos of the first syringe. 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: 18-DEC-2023 18:30 PM :Attachment added to Service Cloud. 18-DEC-2023 18:30 PM :Email received in the mailbox on 18-DEC-2023 at 4:06 PM with photos. See attachment. 18-DEC-2023 18:30 PM :Attachment added to Service Cloud. 18-DEC-2023 18:30 PM :Attachment added to Service Cloud. 18-DEC-2023: DPOC email received with images and attachments, same added in record. As per narrative, photo and script answer review, HCP reports that both syringes were broken in the same way i.e. broken at finger flange. hcp reports that the 1st syringe was discovered broken at the sight of the finger flange, upon opening the packaging. HCP reports the second sryinge was broken at the exact same point of the syringe, the finger flange. hcp reports that second syringe broke while administering the dose to the patient. That means both syringes finger flange was broken. 1 syringe upon opening the package and 1 syringe during administrating the dose to patient hence PQC category selected as "Broken Syringe>>Flange" and "Broken Syringe>>Flange Broken During or After injection" respectively. Device reportability fields selected as per PQC category "Broken Syringe>>Flange - Broken During or After injection" since as per this PQC 'Malfunction' and 'reportable' is 'Yes'. No. of occurrence considered as each 1 syringe have 1 single defect and comp. unit reported defective taken as 2 since reporter reported 2 broken syringes.  19-DEC-2023: Second person review completed. 19-DEC-2023 10:30 AM :Attachment added to Service Cloud. 19-DEC-2023 10:30 AM :Awaiting retrieval site from Quality -- See Attachment 19-DEC-2023 12:30 PM :Attachment added to Service Cloud. 19-DEC-2023 12:30 PM :Retrieval site is reported. 19-DEC-2023 12:30 PM :Mailing labels created for facility. Shipped on 19-DEC-2023. Tracking Numbers: provided Complaint Description Summary SYRINGE 1 was discovered broken in 2 pieces at the sight of the finger flange, while it was still in the tray. SYINGE 2 broke at the sight of the finger flange while administering a single dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) to a patient. ; Sender's Comments:  US-009507513-2312USA007570: