Sex: U
Vaccine: HPV9, HPV9
Symptoms: Syringe issue
Clinical narrative: No adverse event; 2 Gardasil 9 Syringes were broken; Syringe # 2 of GARDASIL 9 was cracked; Caller reports 2 Broken HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9 PFS).  Syringe #1 was found to be broken after removing from tray.  Syringe #2 was seen broken while still in its tray with the cellophane cover still in place.  Caller will send pictures and will hold product for return.  No AE reported.  QUESTION SECTION:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.   Notes:  A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe was considered broken when the syringe is in 2 or more pieces. A syringe was 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 ON SYRINGE #2 STILL IN TRAY If yes, describe the size, shape & depth of the crack: 1/4 INCH PIECE OF FINGER FLANGE IS BROKEN OFF AND MISSING Provide the exact location of the crack on the syringe: FINGER FLANGE  Is the syringe broken into 2 or more pieces? YES ON SYRINGE #1 If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) ROUND FINGER FLANGE MOVES UP AND DOWN BARRELL Provide the exact location of the breakage on the syringe?  FINGER FLANGE  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.  ROUND FINGER FLANGE MOVES UP AND DOWN BARRELL AND PART OF IT IS MISSING 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? NA- DID NOT TRY TO ATTACH THE 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 FOR #2          If yes, is there product (liquid or dried residue) in the tray? NO         Is there any broken glass or other separated component in the tray? (if yes specify) YES 2 PIECES OF GLASS         After removing the syringe from the tray? YES FOR SYRINGE #1           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           If no, describe issue:   Was the syringe tray intact and undamaged on receipt? YES          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          If no, describe damage   Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) NO            If yes, describe   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:   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: