Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: No adverse event; Sterile Injectable;Broken;Syringe Hub Defect; Customer reported a malfunctioned VAXNEUVANCE syringe. She said when she opened the box to take a syringe out, she noticed one of the VAXNEUVAXNCE prefilled syringe was broken. Patient did not miss the dose. She used another syringe from the pack on the patient. No AE reported. No additional PQC reported. Mailer sent. 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:                 - Provide the exact location of the crack on the syringe:         - 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.); CALLER SAID IT IS BROKEN FROM THE TOP WHERE YOU WOULD ATTACH THE NEEDLE                 - Provide the exact location of the breakage on the syringe?  WHERE YOU WOULD ATTCH THE NEEDLE          - Does the syringe have a broken component? NA (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) NA                 - 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 there difficulty trying to attach the syringe needle to the syringe? NA                    - 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? NA                 - 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 removing the syringe from the tray? YES          - While trying to attach the needle to the syringe? NA           - While giving the injection? NA           - Immediately after giving the injection? NO  - Was the syringe tip cap attached properly prior to use? NA          - 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)? NO  - If complaint sample is not/cannot be returned, please provide reason:   *If photos are available, ask the customer to send them: CALLER SAID SHE WOULD SEND THE PICTURES  Retrieval Information:  - Obtain product (& tray if possible): CALLER SAID SHE WOULD SEND THE SYRINGE BACK WHEN SHE RECEIVES THE MAILER - 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:  13-OCT-2022 11:30 AM :Attachment added.  13-OCT-2022 11:30 AM :Attachment added.  13-OCT-2022 11:30 AM :Attachment added.  13-OCT-2022 11:30 AM :Email received in Contact Center Mailbox on 13-OCT-2022 at 9:30 AM with pictures for this case. See attached.  13-OCT-2022 Employee 1 - Picture received and attached in reference tab.  13-OCT-2022 Employee 1 -  Notification would be sent to agency asking if there was any exposure of medication to patient due to reported defect.   13-OCT-2022 Employee 1 - Report submitted for second person review.  13-OCT-2022;  Second person reviewed by Employee 2  14-OCT-2022 10:30 AM :Attachment added.  14-OCT-2022 10:30 AM :Email received in PQC Mailbox on 14-OCT-2022 at 6:53 AM with the follow request from Quality: "Request you to confirm if there was any exposure of medication to patient due to reported defect" See attached. Forwarded to case owner for follow up.  14-OCT-2022 11:30 AM :Follow up for note N-806975. There was no exposure of medication to patient.  VAXNEUVAXNCE prefilled syringe was broken.