Sex: F
Vaccine: PNC15
Symptoms: Haemorrhage, Injury associated with device, Syringe issue, Wound
Clinical narrative: Per rep the email he received reported that a employee was administering VAXNUVANCE and was cut by the syringe.It was report that the glass at the base broke while the medical member was pushing the plunger in.; Per rep the email he received reported that a employee was administering VAXNUVANCE and was cut by the syringe.It was report that the glass at the base broke while the medical member was pushing the plunger in.; Per rep the email he received reported that a employee was administering VAXNUVANCE and was cut by the syringe.; This spontaneous report was received from a licensed practical nurse (LPN) refers to a female patient of unknown age.   Current condition, medical history and concomitant medication was not provided.  On 16-FEB-2023, the medical member (nurse) had contact due to preparation and vaccination with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # W021510 for prophylaxis. On the same date, she experienced injury associated with device (also reported as cut by the syringe). It was reported that the glass at the base broke while the medical member was pushing the plunger in. The product had blood on it since the nurse was cut due to the syringe braking (wound). The ring around the syringe at the flange was shattered, but it was reported that the actual syringe barrell broke (syringe broken). The syringe broken was noticed while injectin it to the patient (also reported was that the syringe was still on the tray). Reporter did not know if the patient missed a dose or any other information about the event.  The outcome of injury associated with device, wound and syringe broken was unknown. Causality between injury associated with device and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was unknown. Causality between wound and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was unknown.  Lot number [W021510] has been verified to be a valid lot number for pneumococcal 15v conj vaccine (crm197).  This is one of multiple reports received from the same reporter.  Follow up information recived on 17-FEB-2023:  Case reopened to include product quantity 1, and product type changed to 'Strength'. No additional AE/PQC reported.  Complaint Description Detail  Per rep the email he received reported that a employee was administering VAXNUVANCE and was cut by the syringe. It was report that the glass at the base broke while the medical member was pushing the plunger in. Caller did not know if the patient missed a dose or any other information about the event. The customer attached to the cases is the one who sent the email to the agency. The agency reported they he should be able to forward the email that was sent to him. The CASE number was provided to caller. LOT: W021510 EXP: 08-OCT-2023.  QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for Agency: 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. PER CALLER it SHATTERED IT WAS THE RING AROUND THE SRYINGE AT THE FLANGE. 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? NA 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? YES If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) SHATTERED Provide the exact location of the breakage on the syringe? WHERE THE FLANGE IS LOCATED Does the syringe have a broken component? YES/NO/NA/UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) If yes, describe in detail how it is broken. SHATTERED AT THE FLANGE IT BUT IT WAS THE ACTUAL SRYINGE BARRELL THAT BROKE Provide the exact location of the breakage on the syringe? SHATTERED AT THE FLANGE IT BUT IT WAS THE ACTUAL SRYINGE BARRELL THAT BROKE Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES/NO/NA/UNSPECIFIED (if yes describe) SHATTERED AT THE FLANGE IT BUT IT WAS THE ACTUAL SRYINGE BARRELL THAT BROKE Was there difficulty trying to attach the syringe needle to the syringe? NA 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 INJECTIN IT TO THE PATIENT While the syringe was still in the tray? YES 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? (if yes specify) NA After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NA While giving the injection? YES Immediately after giving the injection? NO Was the syringe tip cap attached properly prior to use?NA If no, describe issue: NA Was the syringe tray intact and undamaged on receipt? YES 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. YES If no, describe damage NA Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO If yes, describe NA Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? THE PRODUCT HAD BLOOD ON IT SINCE THE NURSE WAS CUT DUE TO THE SRYING BREAKING WHILE SHE WAS INJECTION IT INTO THE PATIENT. If complaint sample is not/cannot be returned, please provide reason: PER CALLER IT HAD TO MUCH BLOOD ON IT TO KEEP TO SEND BACK AND THEY DID NOT TAKE PICTURES If photos are available, ask the customer to send them to email 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: 16-FEB-2023 16:30 PM: Outbound call made to a Licensed Practical Nurse (LPN). Reporter told agent she would have the most information about the event Licensed Practical Nurse was able to provided information in note N-830754. 17-FEB-2023 First reviewer: Note: Based on the complaint's narrative, it seems that the breakage (at the syringe barrel) happened during administering the product. Hence, the PQC category Broken Syringe: Broken During or After injection has been selected. As the complained product had too much blood on it, the photographs of the defective product were not taken.  17-FEB-2023: Second reviewer: Second person review completed  Complaint Description Summary It was report that the glass at the base broke while the medical member was administering VAXNUVANCE.  Executive Summary <Not Set>  This case has been upgraded due to DRR.  Follow-up information recived on 24-FEB-2023:  Reporter information was updated (adress).  Reporter provided that this was the secont time in the last couple of month that this office had an issue with broken syringe. There is also reported that there was a problem last month with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) wich was broken in the same place in the packaging. ; Sender's Comments:  US-009507513-2302USA005782: