Age: 1.33
Sex: M
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: No additional AE, no PQC; HCP calling to report PQC of VAXNEUVANCE that was administered to a patient. Caller stated while administering the medication a plastic piece of the finger flange broke from the syringe and was left hanging on the syringe. Caller stated patient did r; HCP calling to report PQC of VAXNEUVANCE that was administered to a patient. Caller stated while administering the medication a plastic piece of the finger flange broke from the syringe and was left hanging on the syringe. Caller stated patient did r; This spontaneous report was received from a registered nurse and refers to a 16-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JAN-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe, 0.5 milliliter, lot # reported and confirmed as: X022026, expiration date was reported and confirmed as: 22-OCT-2025 (site and route of administration were not provided) for prophylaxis. While administering the vaccine, a plastic piece of the finger flange broke from the syringe and was left hanging on the syringe (syringe issue; poor quality device used). The patient did received the dose and no one was injured during the event. The reporter stated product was available for retrieval and photos would be sent. There was no additional adverse event (AE) reported.   Complaint Description Detail Health Care Professional (HCP) calling to report product quality complaint (PQC) of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) that was administered to a patient. Caller stated while administering the medication a plastic piece of the finger flange broke from the syringe and was left hanging on the syringe. Caller stated patient did receive the dose and no one was injured during the event. Caller stated product is available for retrieval and photos will be sent to email. No additional information provided. No additional AE/PQC reported. QUESTION SECTION: For CSR: Medium Risk: Stuck or Loose; Medium + Risk: Missing - QC Prefilled Syringe Device Plunger Rod and Stopper Irregularity Plunger or Stopper Fell out Missing Stuck Loose Damaged Bent Broken Medium Risk: Stuck or Loose - Medium + Risk: Missing  Which irregularity occurred: (select one below) - Plunger rod (only) fell out of syringe barrel during use or is loose? YES/NO/NA/UNSPECIFIED (if yes, specify which) - If the plunger rod fell out, confirm if the rubber stopper remained in the syringe barrel)  - Plunger rod & stopper fell out of syringe barrel during use or is loose? YES/NO/NA/UNSPECIFIED (if yes, specify which) Plunger rod would not move? YES/NO/NA/UNSPECIFIED If yes, was resistance felt while pulling the plunger rod or pushing the plunger rod: (specify which)  - Plunger rod missing, i.e. not in the tray? YES/NO/NA/UNSPECIFIED  - Plunger rod & stopper missing? YES/NO/NA/UNSPECIFIED  - Plunger rod appeared to move without being touched? YES/NO/NA/UNSPECIFIED  - Plunger rod is damaged; bent; broken or discolored? YES/NO/NA/UNSPECIFIED If yes, please describe defect in detail.  - Syringe stopper is damaged, malformed or discolored? YES/NO/NA/UNSPECIFIED If yes, please describe in detail.  - Under which situation was this defect noticed: (select one below) While still in the tray? YES/NO/NA/UNSPECIFIED  - After removing the syringe from the tray &/or preparing the syringe for injection? YES/NO/NA/UNSPECIFIED If yes, describe what actions were occurring when the defect happened.  - While giving the injection? YES/NO/NA/UNSPECIFIED If yes, describe the actions occurring when defect happened or was noticed?  - Was the syringe tray intact and undamaged on receipt? YES/NO/NA/UNSPECIFIED If no, describe damage.  - If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? see below YES/NO/NA/UNSPECIFIED If no, describe damage  - Was the syringe carton damaged? (i.e. crushed, ripped, unglued) YES/NO/NA/UNSPECIFIED If yes, describe  - Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES/NO/NA/UNSPECIFIED  - If complaint sample is not/cannot be returned, please provide reason:  - If photos are available, ask customers to send photos  Retrieval Information: -Obtain product (& tray if possible) NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details:  06-FEB-2024 15:00:QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for RA: - 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: n/a Provide the exact location of the crack on the syringe: n/a  - Is the syringe broken into 2 or more pieces? NO If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) n/a Provide the exact location of the breakage on the syringe? Finger flange, broken piece is still attached  - Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) If yes, describe in detail how it is broken. Finger Flange, broken piece is still attached Provide the exact location of the breakage on the syringe? Finger Flange Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO  - Was anyone injured as a result of the breakage? NO - If yes, provide brief description of injury - Note to RA: 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 If yes, was it supplied by Company: NO If not supplied by Company, what type & brand, needle size & gauge was used?'  - Under what situation was this defect noticed: (select one) - While the syringe was still in the tray? NA 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)  - After removing the syringe from the tray? NA  - While trying to attach the needle to the syringe? NA  - While giving the injection? YES  - Immediately after giving the injection? NA  - Was the syringe tip cap attached properly prior to use? YES If no, describe issue:  - Was the syringe tray intact and undamaged on receipt? YES If no, describe damage. 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  - Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO If yes, describe  - Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES ADMINISTERED  - If complaint sample is not/cannot be returned, please provide reason: If photos are available, ask the customer to send them   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.  06-FEB-2024 15:00: Attachment added to Service Cloud. 06-FEB-2024 15:00: Attachment added to Service Cloud. 06-FEB-2024 15:00: Attachment added to Service Cloud. 06-FEB-2024 15:00: Attachment added to Service Cloud. 06-FEB-2024 15:00:Awaiting retrieval site from Quality -- See Attachment 06-FEB-2024 15:30: Attachment added to Service Cloud. 06-FEB-2024 15:30: Email received to inbox on 06-FEB-2024 at 12:22 with pictures of affected product. See attached. 07-FEB-2024: HA/Company employee - Email with image received has been attached in the reference tab. - The complainant reported that while administering the medication a plastic piece of the finger flange broke from the syringe and was left hanging on the syringe. Based on the image review, the flange seems to be separated with an extended breakage on the syringe barrel. Hence, complaint categories 'Broken Syringe >> Broken During or After injection' and 'Broken Syringe >> Flange-Broken During or After injection' have been taken and assigned to manufacturing site for investigation. Packaging site added in database conservatively since Flange also is broken. 07-FEB-2024 HA/Company employee: Second person review is done. Perform e-sign. 07-FEB-2024 10:00: Email received in the PQC Mailbox on 07-FEB-2024 at 6:42 with the following from quality: "PQC acknowledged" See attached. 07-FEB-2024 10:00:Attachment added to Service Cloud. 07-FEB-2024 12:00: Attachment added to Service Cloud. 07-FEB-2024 12:00: Retrieval site reported. 07-FEB-2024 12:00: Labels created for location. Shipped on 02-FEB-2024. Tracking Numbers: - Outbound 1Z1746840195387499 - Return 1Z1746848491143648  Complaint Description Summary While administering the medication a plastic piece of the finger flange broke from the syringe and was left hanging on the syringe.