Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: Sterile Injectable;N/A;Broken Syringe; No adverse event; Company employee called to report that a nurse informed her HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) arrived broken. She stated that she had pictures and the customer's invoice available and would send photos. No AE reported. Replacement case#02217263.   after reviewing photos, it appears that two HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) syringes still in plastic tray have the finger flanges broken.   Unable to reach customer at this time, submitting case with limited information and will attempt further contact with nurse to collect/confirm PQC details. 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:  02-Aug-2022 14:30 PM :Email received in the Mailbox on 2-AUG-2022 at 12:50pm with pictures related to this case. The email also contains the facility's invoice for the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). See attached.  02-Aug-2022 14:30 PM :QUESTION SECTION:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.   Notes for DPOC:  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? 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/NO/NA/UNSPECIFIED  If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.)  Provide the exact location of the breakage on the syringe?    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) If yes, describe in detail how it is broken. Provide the exact location of the breakage on the syringe?  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)   Was there difficulty trying to attach the syringe needle to the syringe? YES/NO/NA/UNSPECIFIED   If yes, describe   If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED   If not supplied by MERCK, what type & brand, needle size & gauge was used?'  Under what situation was this defect noticed: (select one)   While the syringe was still in the tray? YES/NO/NA/UNSPECIFIED    If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED    Is there any broken glass or other separated component in the tray? (if yes specify)     After removing the syringe from the tray? YES/NO/NA/UNSPECIFIED   While trying to attach the needle to the syringe? YES/NO/NA/UNSPECIFIED    While giving the injection? YES/NO/NA/UNSPECIFIED    Immediately after giving the injection? YES/NO/NA/UNSPECIFIED  Was the syringe tip cap attached properly prior to use? YES/NO/NA/UNSPECIFIED  If no, describe issue:  Was the syringe tray intact and undamaged on receipt? YES/NO/NA/UNSPECIFIED  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/NO/NA/UNSPECIFIED If no, describe damage  Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) YES/NO/NA/UNSPECIFIED  If yes, describe  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES/NO/NA/UNSPECIFIED  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.  02-Aug-2022 14:30 PM :Outbound call 1 made at 1:39pm. Phone option 1, then left a message on VM for "back office." phone# and case# left for reference. If customer does not call back, 2 additional attempts will be made within the next 7 business days in an attempt to collect PQC details. On callback, please ask all PQC questions from previous note. Determine if PFS with broken finger flanges are available for retrieval. Confirm details from case 02217263 to request a replacement for customer.  02AUG-2022 Based on the review of the PQC the priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk. 02-AUG-2022  Received & Attached Photos. 02-AUG-2022  Requested to please confirm with the reporter how many of the syringes were received broken.   02-AUG-2022 16:30 PM :Attachment added.  02-AUG-2022 16:30 PM :Email received in the 0Mailbox on 02-AUG-2022 at 3:31pm with the following request from quality: "Can you please reach out to the reporter and ask them how many syringes were broken?" See attached. Forwarded to case owner for follow up.  03-AUG-2022  2022-08-02T16:43:23-04:00 Response to quality email: "Outbound call# 1 made at 1:39pm; left a message on VM; phone# and case# left for reference; 2 additional attempts will be made within the next 7 business days in an attempt to collect PQC details. "