Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: no adverse event; the syringe broke while attempting to put the safety cap on after administration of VAXNEUVANCE; the syringe broke while attempting to put the safety cap on after administration of VAXNEUVANCE; Complaint Description Summary HBP calling to report the syringe broke while attempting to put the safety cap on after administration of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE).  Complaint Description Detail HBP calling to report the syringe broke while attempting to put the safety cap on after administration of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE). HBP reports the product was disposed of in a sharps container and was unavailable for return and no pictures were taken. HBP confirmed office was not looking for replacement as the patient received the full dose and no injuries were involved. HBP inspected the entire package and there did not appear to be any damage to any other product or the package. No further details provided. No AE and no other PQC. 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 was considered broken when the syringe is in 2 or more pieces. A syringe was 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: Provide the exact location of the crack on the syringe: Is the syringe broken into 2 or more pieces? YES 2 PIECES If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.)-Snapped in half Provide the exact location of the breakage on the syringe? Syringe Does the syringe have a broken component? NO (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) If yes, describe in detail how it is broken. Provide the exact location of the breakage on the syringe? 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) Was anyone injured as a result of the breakage? No If yes, provide brief description of injury Note: 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 MERCK: YES/NO/NA/UNSPECIFIED If not supplied by MERCK, 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? No If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED Is there any broken glass or other separated component in the tray? (if yes specify) After administration After removing the syringe from the tray? No While trying to attach the needle to the syringe? No While giving the injection? NO Immediately after giving the injection? YES , snapped after attempting to replace safety cover 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? No 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: Unavailable as product was disposed of in a sharps container If photos are available, ask the customer to send them Already disposed in the Sharps container  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: 24-JUL-2023 at 18:30: Update applied 25-JUL-2023 Reviewer 1: Recieved an email on 25-JUL-2023 at 10:44 with the case snapshot. The email was attached to the record in the reference tab. - The complaint description stated, "Healthcare professional calling to report the syringe broke while attempting to put the safety cap on after administration of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE)" and the PQC intake questions are answered as below: Is the syringe broken into 2 or more pieces? YES 2 PIECES Provide the exact location of the breakage on the syringe? Syringe Under what situation was this defect noticed: Immediately after giving the injection? YES , snapped after attempting to replace safety cover. - Based on the complaint description and the answers to PQC questions, the record is being categorized under, Broken Syringe - Broken During or After Injection. - Agency will be notified to confirm if the barrel of the syringe broke or is the defect related to Syringe Hub. 25-JUL-2023 Reviewer 2: Second person reviewed. Perform e-sign. 25-JUL-2023 at 09:30: Attachment added. 25-JUL-2023 at 09:30: Email received in the Mailbox on 25-JUL-2023 at 4:11 with the following request from quality: "The questions are answered as below: Is the syringe broken into 2 or more pieces? YES 2 PIECES Provide the exact location of the breakage on the syringe? Syringe. Kindly confirm if the syringe barrel broke in to two pieces? Or is the defect related to the syringe hub? The information is very critical, kindly provide revert at the earliest." See attached. Forwarded to case owner for follow up. 26-JUL-2023 Reviewer 1: As per the update recieved from agency via interface (Updated on 25-JUL-2023 at 09:30), there was no new information relating to PQC. Hence, Lead will not be notified. 26-JUL-2023 Reviewer 1: Following information was failed to update via interface on 25-JUL-2023: Outbound call made on 25-JUL-2023 at 9:27 to healthcare professional to confirm the location of where the syringe broke. Healthcare professional stated the break was at the flange. The file with the update is attached to the record in the reference tab. As per the update, since the syringe broke at the finger flange, no change in complaint category is required. Lead will be notified of the update.