Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;N/A;Broken Syringe; Complaint description detail  Emails received in the Mailbox on 02AUG2022 at 3:15PM, 3:18PM, 3:24PM, and 3:42PM reporting a PQC for GARDASIL 9 from a HCP. Message verbatim: "We received a broken syringe of Gardasil 9 and would like to know what we can do to get a replacement if possible.  The box was not damaged and the other 9 syringes were fine when we received the order." See attached. No AE or additional PQC reported. No additional information provided. 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 17:30 PM :Attachment added.  02-AUG-2022 17:30 PM :Attachment added.  02-AUG-2022 17:30 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? NO                 If yes, describe the size, shape & depth of the crack: NA                 Provide the exact location of the crack on the syringe: NA         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.) ROUND PIECE AROUND THE PLUNGER AREAD BROKE OFF AND THEN SOME PIECES WERE SHATTERED FROM THE BROKEN EDGES; IT IS BROKEN IN TWO PIECES                 Provide the exact location of the breakage on the syringe? AREA AROUND THE PLUNGER          Does the syringe have a broken component? CALLER SAID NO, BUT DESCRIBED WHAT SOUNDED LIKE THE SYRINGE BARREL                 If yes, describe in detail how it is broken. BROKEN IN TWO PIECES                 Provide the exact location of the breakage on the syringe? ROUND AREA AROUND THE PLUNGER                 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? NA                    If yes, describe: NA                    If yes, was it supplied by MERCK: NA                    If not supplied by MERCK, what type & brand, needle size & gAUGe was used?: NA  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 MEDICATION IS STILL IN THE SYRINGE                  Is there any broken glass or other separated component in the tray? YES           After removing the syringe from the tray? NA           While trying to attach the needle to the syringe? NA            While giving the injection? NA            Immediately after giving the injection? NA   Was the syringe tip cap attached properly prior to use? NA           If no, describe issue: NA   Was the syringe tray intact and undamaged on receipt? YES          If no, describe damage. NA   If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  *See below. YES          If no, describe damage NA   Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) NO           If yes, describe NA   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: REPORTER AGREED TO RETURN GARDASIL 9  *If photos are available, ask the customer to send them REPORTER AGREED TO SEND PHOTOS 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 17:30 PM :Attachment added.  02-AUG-2022 17:30 PM :Outbound call was placed to customer to obtain answers to the PQC questions. Caller provided PQC details and agreed to send photos as well as return the broken syringe. No AE or additional PQC reported. No additional information provided.  02-AUG-2022 17:30 PM :Attachment added.  02-AUG-2022: The priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table.  02-AUG-2022: email containing reporter correspondence received & attached  03-AUG-2022; Second person reviewed  03-AUG-2022 12:30 PM :Waiting for Retrieval Site from Quality--See attachments  03-AUG-2022 12:30 PM :Attachment added.  03-AUG-2022 16:30 PM :Attachment added.  03-AUG-2022 16:30 PM :UPS Labels created 03-AUG-2022    03-AUG-2022: Received & Attached email sent.  03-AUG-2022: Received & attached Photos.  03-AUG-2022 17:30 PM :Attachment added.  03-AUG-2022 17:30 PM :Email received in the Mailbox on 03-AUG-2022 at 4:47pm with pictures for this case. See attached.