Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: No adverse event; Sterile Injectable;N/A;Broken Syringe; Merck representative calling on behalf of the customer who reported a shipment of GARDASIL 9 was damaged when received. Caller stated the customer sent pictures of the damage and will email to agency.  Outbound call placed to customer who stated the shipment was received on a prior date, however, the box was not needed until today 08-AUG-2022. When the product box was opened, the damage was noted on  the flange. Customer will hold product for mailer. No AE. No additional PQC. Attachment added to system. 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:  08-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 Agency:  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? NO If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) NA Provide the exact location of the breakage on the syringe?  NA  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. FINGER FLANGE BROKEN  Provide the exact location of the breakage on the syringe? FINGER FLANGE  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? NO, DID NOT ATTEMPT TO ATTACH SYRING NEEDLE. 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? UNSPECIFIED Is there any broken glass or other separated component in the tray? (if yes specify) YES, PART OF THE FLANGE  After removing the syringe from the tray? NO 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? YES/NO/NA/UNSPECIFIED If no, describe issue:  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: NA  If photos are available, ask the customer to send them to email  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.  08-AUG-2022 17:30 PM :Attachment added to system.  09-AUG-2022: First person: PHOTOS received from Agency attached, it should be noted, that the original file size is too large to attach, therefore, the photos were attached individually.  09-AUG-2022: First person: Instructed Agency retrieval site  09-AUG-2022;  Second person reviewed  09-AUG-2022 10:30 AM :Attachment added to System.  09-AUG-2022 10:30 AM :Email received in the PQC Mailbox on 9-AUG-2022 at 9:13am from quality stating: "Pls. route return mailer to agency." Email forwarded to mail team. See attached.  09-AUG-2022 17:30 PM : Labels created for agency  09-AUG-2022