Sex: U
Vaccine: HPV9
Symptoms: Needle issue, Syringe issue
Clinical narrative: No adverse event; Sterile Injectable;N/A;Broken Syringe; Field-based employee submitting a PQC for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on behalf of a medical assistant. Caller stated the MA reported that while she was putting a needle on a pre-filled syringe of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), "the bottom part snapped off". Caller stated he will forward pictures provided by the MA. Product was not administered to patient. No additional information provided. No AE filed. QUESTION SECTION:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes:  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? NO                 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                 o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) Broken in 2 pieces                 o Provide the exact location of the breakage on the syringe? at finger flange          o Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange)                 o If yes, describe in detail how it is broken. finger flange broken off                 o Provide the exact location of the breakage on the syringe? see attached photos                 o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO          o Was there difficulty trying to attach the syringe needle to the syringe? NO                    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? NO                 o 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)          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? YES, prior to           o Immediately after giving the injection? NO  o Was the syringe tip cap attached properly prior to use? YES          o If no, describe issue:  o Was the syringe tray intact and undamaged on receipt? 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. UNSPECIFIED         o If no, describe damage  o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNSPECIFIED           o If yes, describe  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO  o If complaint sample is not/cannot be returned, please provide reason: discarded into sharps container  *If photos are available  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. 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:  21-MAY-2022 24:07 AM: Attachment added to Service Cloud.  21-MAY-2022 24:07 AM: Email received in the Contact Center mailbox on 20-MAY-2022 at 5:14 pm with pictures associated for this case. See attachment.  23-MAY-2022: Received & Attached Photo. 23-MAY-2022; Notification: 02170050; Please confirm if 5004U00000xGfAKQA0:02170050 is a duplicate of 5004U00000xGfAPQA0:02170050. Thank you 23-MAY-2022: Second person reviewed.  23-MAY-2022 12:30 PM: Update applied 23-MAY-2022; Notification: 02170050;  Please discard request of duplicate complaint (Please confirm if 5004U00000xGfAKQA0:02170050 is a duplicate of 5004U00000xGfAPQA0:02170050.), I see 5004U00000xGfAPQA0:02170050 is for hepatitis a vaccine, inactivated (VAQTA) and this record is for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). thank you  23-MAY-2022 13:30 PM: Attachment added to Service Cloud.  23-MAY-2022 13:30 PM: Email received in the PQC Mailbox on 23-MAY-2022 at 10:31am asking if this case is a duplicate of another unspecified case. See attachment. Unable to determine if case is a duplicate without additional case/interaction number.  23-MAY-2022 13:30 PM: Attachment added to Service Cloud.  23-MAY-2022 13:30 PM: Email received in the PQC Mailbox on 23-MAY-2022 at 12:35pm with the following from quality: "Please discard request of duplicate complaint (Please confirm if 5004U00000xGfAKQA0:02170050 is a duplicate of 5004U00000xGfAPQA0:02170050.), I see 5004U00000xGfAPQA0:02170050 is for hepatitis a vaccine, inactivated (VAQTA) and this record is for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). thank you" See attached.  23-MAY-2022: Requested to ask the reporter the following below-  "Can you please inquire about the unlabeled syringe photo? Is the syringe label available and can we get photos of the label?"  23-MAY-2022 16:30 PM: Attachment added to Service Cloud.  23-MAY-2022 16:30 PM: Email received in PQC Mailbox on 23-MAY-2022 at 3:03pm with the following request from Quality: "Can you please inquire about the unlabeled syringe photo? Is the syringe label available and can we get photos of the label?" See attached. Forwarded to case owner.  23-MAY-2022 18:30 PM: Agent made outbound call to inquire if either the label or syringe were available. Customer stated that they removed the label from the syringe to place it in their records, but both the label and the syringe were currently unavailable as they were disposed of. Customer states she was not able to produce any additional photos of the syringe or label. No additional information provided.