Sex: U
Vaccine: HPV9, HPV9
Symptoms: Syringe issue
Clinical narrative: Sterile Injectable;N/A;Broken Syringe; No adverse event; Complaint Description Detail  Email received in the PQC mailbox on 03-OCT-2022 at 3:42 pm with PQC: Report verbatim: "This provider received several hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) doses with broken vials. The vaccine was shipped from the warehouse to the provider, but it was initially shipped from warehouse." See attachment. Within the attachment the customer mentions on 30-SEP-2022 "We discovered that 2 syringes of HPV vaccine (lot U031056, exp 6/16/24) were broken in the packaging. I called and notified manufacturer about this, and they said to let you all know. I will plan to waste these two doses in our reconciliation when I order vaccines next week." I am unable to locate original case, company awareness date reflects the date the email was received in the mailbox.  No AE reported on attachment. Will follow up. Attachment added. 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:  03-OCT-2022 17:30 PM: QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.   Notes for DPOC:  o 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. o 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).  o Please provide a detailed description of the defect using the questions below:        o Is there a crack? YES/NO/NA/UNSPECIFIED                 o If yes, describe the size, shape & depth of the crack:                 o Provide the exact location of the crack on the syringe:         o Is the syringe broken into 2 or more pieces? YES/NO/NA/UNSPECIFIED                 o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.)                 o Provide the exact location of the breakage on the syringe?          o 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)                 o If yes, describe in detail how it is broken.                 o Provide the exact location of the breakage on the syringe?                 o 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)          o Was there difficulty trying to attach the syringe needle to the syringe? YES/NO/NA/UNSPECIFIED                    o If yes, describe                    o If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED                    o If not supplied by MERCK, what type & brand, needle size & gauge was used?'  o Under what situation was this defect noticed: (select one)         o While the syringe was still in the tray? YES/NO/NA/UNSPECIFIED                 o If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED                 o Is there any broken glass or other separated component in the tray? (if yes specify)          o After removing the syringe from the tray? YES/NO/NA/UNSPECIFIED          o While trying to attach the needle to the syringe? YES/NO/NA/UNSPECIFIED           o While giving the injection? YES/NO/NA/UNSPECIFIED           o Immediately after giving the injection? YES/NO/NA/UNSPECIFIED  o Was the syringe tip cap attached properly prior to use? YES/NO/NA/UNSPECIFIED          o If no, describe issue:  o Was the syringe tray intact and undamaged on receipt? YES/NO/NA/UNSPECIFIED         o If no, describe damage.  o 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         o If no, describe damage  o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) YES/NO/NA/UNSPECIFIED           o If yes, describe  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES/NO/NA/UNSPECIFIED  o If complaint sample is not/cannot be returned, please provide reason:   *If photos are available, ask the customer to send them  Retrieval Information:  o Obtain product (& tray if possible) o 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.  03-OCT-2022 17:30 PM: Outbound call made in attempts to contact customer. Front desk reported that she is not in the office until Wednesday, 05-OCT-2022 but that she might be working remotely on 04-OCT-2022. Case number and phone number left with office staff and a request to contact. I also sent an email to the customer requesting her to contact. Upon call back please have customer answer all PQC questions related to the broken finger flange. Customer also noted that she "called and notified Merck about this" on 30-SEP-2022, however there are no cases located. Please have customer clarify who she spoke with at manufacturer. Will follow up.  04-OCT-2022: Received & attached photos 04-OCT-2022: Requested to please confirm with the reporter, how many syringes were broke, based on the photos provided it only appears to be one. 04-OCT-2022: Second person reviewed  04-OCT-2022 12:30 PM: Attachment added.  04-OCT-2022 12:30 PM: Email received on 04-OCT-2022 at 8:50AM from Quality: "Can you please confirm with the reporter, how many syringes were broken based on the photos provided it only appears to be one?" See attached. Forwarded to case owner for follow up.  05-OCT-2022, Registered Nurse (also reported as Nurse) confirmed that 2 syringes were broken although it was hard to see in photos provided. Broken syringes have been disposed in sharps container and were not available for return.