Sex: U
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: No adverse event, Poor quality product administered, Syringe issue
Clinical narrative: the part that that broke off did cause a small scratch on the administering nurse's right index finger; he vaccine syringe finger phalange broke off from the syringe/Flange - Broken During or After injection; he vaccine syringe finger phalange broke off from the syringe; he vaccine syringe finger phalange broke off from the syringe; This spontaneous report was received from a healthcare professional and refers to a nurse of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 08-SEP-2023, when the pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot number X019197 with expiration date 30-AUG-2025, was being administered to the 6 month old patient (captured in MARRS 2311USA002385). 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 (syringe issue, skin laceration, injury associated with device and poor quality device used).  The outcome of skin laceration was unknown.  The relatedness between the event of skin laceration and therapy with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) was not reported.  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: 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 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: 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.