Age: 0.42
Sex: F
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: No adverse event, Poor quality product administered, Syringe issue
Clinical narrative: no adverse event; Flange - Broken During or After injection/ When vaccine was being administered to the 6 month old patient a part of the vaccine syringe finger phalange; Flange - Broken During or After injection/When vaccine was being administered to the 6 month old patient a part of the vaccine syringe finger phalange; This report was obtained on request by the Company from the FDA (Agency Number 2680947-1) under the Freedom of Information Act.  Information has been received from a healthcare professional and refers to a 5-month-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 08-SEP-2023, the patient was vaccinated with the third dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE), intramuscularly in the left leg, lot number X019197, expiration date not reported but upon internal validation established as 30-AUG-2025 for prophylaxis.  On 08-SEP-2023, when the pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) was being administered to the 6 month old patient a part of the vaccine syringe finger phalange broke off from the syringe. Pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) was fully administered and there were no complications or injuries that occurred to the patient. The small plastic piece that broke off from the syringe did not enter the vaccine part of the syringe, no contamination to vaccine occurred (Syringe issue). The part that broke off did cause a small scratch on the administering nurse's right index finger that did not require any treatment other than use of a band-aid and injury healed 2 days after incident.   At the time of the report, the outcome of the event was reported as recovered.  This is one of two reports from the same source.  Complaint description detail. When vaccine was being administered to the 6-month-old patient a part of the vaccine syringe finger phalange broke off from the syringe. Vaccine was fully administered and there were no complications or injuries that occurred to the patient. The small plastic piece that broke off from the syringe did not enter the vaccine part of the syringe, no contamination to vaccine occurred. The part that broke off did cause a small scratch on the administering nurse's right index finger that did not require any treatment other than use of a band-aid and injury healed 2 days after incident. See attached. Some fields marked "Unknown" as they were not included in the report. No further information available. No additional AE/PQC reported. VAERS ID: 2680947-1 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? UNSPECIFIED - RECEIVED BY EMAIL If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) UNSPECIFIED - RECEIVED BY EMAIL Provide the exact location of the breakage on the syringe? UNSPECIFIED - RECEIVED BY EMAIL Does the syringe have a broken component? YES If yes, describe in detail how it is broken. VACCINE SYRINGE FINGER PHALANGE BROKE OFF FROM THE SYRINGE Provide the exact location of the breakage on the syringe? FINGER PHALANGE BROKE OFF FROM THE SYRINGE Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? UNSPECIFIED - RECEIVED BY EMAIL Was anyone injured as a result of the breakage? YES If yes, provide brief description of injury THE PART THAT BROKE OFF DID CAUSE A SMALL SCRATCH ON THE ADMINISTERING NURSE'S RIGHT INDEX FINGER THAT DID NOT REQUIRE ANY TREATMENT OTHER THAN USE OF A BAND-AID AND INJURY HEALED 2 DAYS AFTER INCIDENT. 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? UNSPECIFIED - RECEIVED BY EMAIL If yes, describe NA 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? NO If yes, is there product (liquid or dried residue) in the tray? NA Is there any broken glass or other separated component in the tray? NA After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While giving the injection? YES Immediately after giving the injection? NO Was the syringe tip cap attached properly prior to use? UNSPECIFIED - RECEIVED BY EMAIL If no, describe issue: NA Was the syringe tray intact and undamaged on receipt? UNSPECIFIED - RECEIVED BY EMAIL If no, describe damage. NA If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? See below. UNSPECIFIED - RECEIVED BY EMAIL If no, describe damage NA Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) UNSPECIFIED - RECEIVED BY EMAIL If yes, describe NA Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES - WHEN VACCINE WAS BEING ADMINISTERED TO THE 6 MONTH OLD PATIENT A PART OF THE VACCINE SYRINGE FINGER PHALANGE BROKE OFF FROM THE SYRINGE. VACCINE WAS FULLY ADMINISTERED AND THERE WERE NO COMPLICATIONS OR INJURIES THAT OCCURRED TO THE PATIENT. If complaint sample is not/cannot be returned, please provide reason: REPORT RECEIVED BY EMAIL - NO CONTACT INFORMATION AVAILABLE TO CONFIRM IF PRODUCT CAN BE RETURNED If photos are available, ask the customer to send them to EMAIL REPORT RECEIVED BY EMAIL NO CONTACT INFORMATION AVAILABLE TO CONFIRM IF PRODUCT PICTURES ARE AVAILABLE 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: Unknown Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 07-NOV-2023 16:30 PM: Attachment added to Service Cloud. 08-NOV-2023: DPOC email received with AE and PQC attachment and same added in record. As per narrative review, "When vaccine was being administered to the 6 month old patient a part of the vaccine syringe finger phalange broke off from the syringe" hence PQC category added as "Broken Syringe Flange Broken During or After injection". 08-NOV-2023: Second person reviewed. Perform e-sign.