Sex: F
Vaccine: HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: provider was cut with the glass from the broken syringe after administration; provider was cut with the glass from the broken syringe after administration; Complaint Description Detail: Merck employee (vaccine rep) calling on behalf of office manager to report AE/PQC. States hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in prefilled syringe (PFS) was administered to a patient that was broken or cracked. Outbound call made to office manager who was able to answer PQC questions but was unable to advise patient information. Stated provider was cut with the glass from the broken syringe after administration. AE for provider filed. See AE case 02148344. Office manager unable to provide NDC number but does state she would like replacement. hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) is not available for collection as it has been discarded. No additional AE details. No additional PQC. Note: QUESTION SECTION:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC:  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 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.) RIM HAD BROKEN AWAY AND THERE WERE SHARP PEICES AROUND THE RIM Provide the exact location of the breakage on the syringe? RIM Does the syringe have a broken component? BROKEN SYRINGE TIP If yes, describe in detail how it is broken. BROKEN AROUND THE RIM A FEW PIECES OF GLASS CRACKED OFF DURING ADMINSTRATION Provide the exact location of the breakage on the syringe? RIM Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO Was there difficulty trying to attach the syringe needle to the syringe? NO If yes, was it supplied by MERCK: UNSPECIFIED If not supplied by MERCK, what type & brand, needle size & gauge was used? UNSPECIFIED 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? NA Is there any broken glass or other separated component in the tray? (if yes specify) NO 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 Was the syringe tip cap attached properly prior to use? YES Was the syringe tray intact and undamaged on receipt? YES If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  *See below. UNSPECIFIED Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) NO  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: CANNOT BE RETURNED AS IT HAS BEEN DISCARDED. NO PICTURES AVAILBALE EITHER 15-APR-2022 13:30 PM: Attachment added to system. 15-APR-2022 Reporter: Requested Agency to r each out to the reporter and ask them to clarify what was meant by Broken RIM? Was it the finger flange that was broken and to also confirm if any part of the syringe was broken beside the RIM.  15-APR-2022: Second person review performed by Staff. 15-APR-2022 15:30 PM: Attachment added to system. 15-APR-2022 15:30 PM: Email received in Agency mailbox on 15APR2022 at 2 :23pm from Quality: "Can you please reach out to the reporter and ask them to clarify what was meant by Broken RIM? Was it the finger flange that was broken and to also confirm if any part of the syringe was broken beside the RIM. " Forwarded to case owner f or follow up. 15-APR-2022 15:30 PM: Made outbound call to clarify what was meant by broken RIM. Employee was not available at time of call.  Will attempt another outbound call on the next business day. 15-APR-2022 18 :30 PM: NDC 58160-0976-20 Finger Flange 15-APR-2022 18:30 PM: Inbound call received from customer. Customer confirms she meant finger flange when referring to the RIM of the syringe. No other part of the syringe was broken. Customer also confirmed NDC number. ; Sender's Comments:  US-009507513-2204USA006033: