Sex: U
Vaccine: HPV9
Symptoms: Incorrect disposal of product, No adverse event, Poor quality device used, Product quality issue, Syringe issue
Clinical narrative: no adverse event; After the patient was given the vaccine the administering nurse was putting the safety on the needle, she used her thumb to lower the safety and then push onto the needle, which then caused the luer lock to snap off/break off; Poor quality device used; Improper needle recapping for disposal; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 02-MAY-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T039466, expiration date 20-MAY-2023) as prophylaxis.  On 02-MAY-2022, after the patient was given the vaccine, the administering nurse was putting the safety on the needle, she used her thumb to lower the safety and then push onto the needle, which then caused the luer lock to snap off/break off (syringe issue, incorrect disposal of product and poor quality device used). No adverse event.  Complaint Description Detail  Nurse calling to report a product quality issue with a GARDASIL 9 vaccine. She states that a patient was vaccinated appropriately and without complications. After the patient was given the vaccine, the administering nurse was putting the safety on the needle, she used her thumb to lower the safety and then push onto the needle, which then caused the luer lock to snap off/break off. She states that the safety needle was not a Merck needle and was an office supplied needle. Nurse is not requesting replacement. No additional information. 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 CRACK, IT WAS A CLEAN BREAK o If yes, describe the size, shape & depth of the crack: NA o Provide the exact location of the crack on the syringe: NA Is the syringe broken into 2 or more pieces? YES o If yes, describe in detail how it is broken: (e. g. shattered, broken in half etc . ) ON THE BACK SIDE OF THE PLASTIC LUER LOCK, THE LUER LOCK SNAPPED OFF AFTER THE VACCINE WAS ADMINISTERED AND WHILE THE NURSE WAS ATTEMPTING TO PUT THE SAFETY ON THE NEEDLE (WHICH WAS INCLUDED WITH THE NEEDLE THAT WAS ATTACHED TO THE SYRINGE) THE PRESSURE SNAPPED THE LUER LOCK OFF o Provide the exact location of the breakage on the syringe? AT THE TOP OF THE LUER LOCK, WHERE THE LUER LOCK ATTACHES TO THE GLASS PIECE o Does the syringe have a broken component? YES, CLEAN BREAK OF THE LUER LOCK OFF OF THE SYRINGE o If yes, describe in detail how it is broken. CLEAN BREAK OF THE LUER LOCK OFF OF THE SYRINGE. LUER LOCK SNAPPED OFF AFTER NURSE WAS ATTEMPTING TO PUT THE SAFETY ON THE NEEDLE AND THE PRESSURE OF HER THUMB ON THE SAFETY SNAPPED THE LUER LOCK OFF o Provide the exact location of the breakage on the syringe? WHERE THE LUER LOCK MEETS THE GLASS Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES, THE LUER LOCK SNAPPED/ BROKE OFF. IT WAS A CLEAN BREAK. o Was there difficulty trying to attach the syringe needle to the syringe? NO o If yes, describe NA o If yes, was it supplied by MERCK: NO If not supplied by MERCK, what type & brand, needle size & gauge was used? NEEDLE WITH A BLUE SAFETY CAP, UNSURE OF NEEDLE SIZE/GAUGE Und er what situation was this defect noticed: (select one) o While the syringe was still in the tray? NO If yes, is there product (liquid or dried residue) in the tray? NA o Is there any broken glass or other separated component in the tray? (if yes specify) NA o After removing the syringe from the tray? NO o While trying to attach the needle to the syringe? NO o While giving the injection? NO o Immediately after giving the injection? YES, WHEN ATTEMPTING TO PLACE THE SAFETY ON THE NEEDLE Was the syringe tip cap attached properly prior to use? YES, IT WAS SEATED ON THERE PROPERLY o If no, describe issue: Was the syringe tray intact and undamaged on receipt? YES o 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 o If no, describe damage Was the syringe carton damaged prior to use? (i.e., crushed, ripped, unglued) NO o 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: *If photos are available, ask the customer to send them 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: 04-MAY-2022 14:00 PM: Attachment added to Service. 04-MAY-2022 14:00 PM: Attachment added to Service. 04-MAY-2022 14:00 PM: Attachment added to Service. 04-MAY-2022 Second person reviewed 04-MAY-2022 16: 30 PM: Waiting for Retrieval Site from Quality---See attachments 04-MAY-2022 16:30 PM: Attachment added to Service.  Complaint Description Summary  LUER LOCK SNAPPED OFF AFTER THE VACCINE WAS ADMINISTERED AND WHILE THE NURSE WAS ATTEMPTING TO PUT THE SAFETY ON THE NEEDLE.