Sex: F
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: A broken syringe in the tray / Broken Syringe Barrel; scraped the "top of her knuckle" on her right hand on a broken syringe in the tray / medical assistant's injury; This spontaneous report was received from a certified medical assistant referring to a female patient of unknown age. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.      On 26-OCT-2022, another medical assistant was reaching in to get a pre-filled syringe of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # W010663 which has been verified to be valid, with an expiration date on 11-MAR-2024, for prophylaxis and scraped the "top of her knuckle" on her right hand on a broken syringe in the tray (injury associated with device and syringe issue). The reporter stated the syringe had been retained for retrieval, but the tray had been disposed of and will not be available to retrieve.     It was specified that the syringe was broken on barrel toward finger flange and that this defect was noticed after removing the syringe from the tray. The syringe tray was intact and undamaged on receipt.  It was unknown if the patient received treatment for the event. At the reporting time, the outcome of injury associated with device was unknown.  Please provide a detailed description of the defect using the questions below: Is there a crack? YES/NO/NA/UNSPECIFIED 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 ate.) bottom of barrel near finger flange broken off. Provide the exact location of the breakage on the syringe? on barrel toward finger flange 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. Provide the exact location of the breakage on syringe? on barrel Is 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, describe Under what situation was this defect noticed: (select one) While the syringe was still in the tray? YES If yes, is there product (liquid or dried residue) in the tray? NO Is there any broken glass or other separated component in the tray? (if yes specify) not in the tray After removing the syringe from the tray? YES While trying to attach the needle to the syringe? NO While giving the injection? NO 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. UNSPECIFIED 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:  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.  02-NOV-2022 18:30 PM :Attachment added. Device Related Report Quality Customer Complaints 02-NOV-2022 18:30: Email received in the mailbox on 02-NOV-2022 at 16:23 with pictures associated with this case. See attachment. 02-NOV-2022 18:30: Attachment added. 02-NOV-2022 20:30: Case reopened to update Obtain to True. 03-NOV-2022: Received email contains photos and attachment attached. 03-NOV-2022: Second person review completed. 03-NOV-2022 12:30: Awaiting retrieval site from Quality 11:35 ET 03-NOV-2022. 03-NOV-2022 12:30: Attachment added.  Complaint Description Summary: Caller states that another medical assistant was reaching in to get a pr e- filled syringe of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and scraped the "top of her knuckle" on her right hand on a broken syringe in the tray.