Sex: U
Vaccine: HPV9
Symptoms: Liquid product physical issue, Product packaging issue, Product physical issue, Syringe issue
Clinical narrative: No AE reported; Sterile Injectable;N/A;Broken SyringeSterile Injectable;N/A;Package Physical Damage; The caller stated that she noticed the box of Gardasil 9 was "bent"; A health care professional (HCP) called and reported a PQC. The caller stated that she noticed the box of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was "bent". The caller stated upon opening the box (on 24-AUG-2022) she found two syringes of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that were both broken. One of the syringes was broken and also had a crack on the syringe. The caller stated the finger flanges on both syringes were broken off. The caller stated she would send pictures to the email and would set aside the damaged syringes the products for retrieval. The HCP confirmed no other vials were damaged in the package. Caller confirmed no AE was associated with this PQC.  No additional information provided. No AE reported. No additional PQC reported. 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? "YES, TWO VIALS WERE BROKEN, BUT ONE VIAL HAS A CRACK IN IT."                 If yes, describe the size, shape & depth of the crack: A CRACK IS ABOUT .5 INCH WITH A PIECE HANGING DOWN OFF OF IT"                 Provide the exact location of the crack on the syringe: "THE FINGER FLANGE"         Is the syringe broken into 2 or more pieces? YES, BOTH SYRINGES ARE BROKEN INTO 2 OR MORE PIECES                 If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) BROKEN IN HALF                 Provide the exact location of the breakage on the syringe? FINGER FLANGES          Does the syringe have a broken component? YES                 If yes, describe in detail how it is broken. BROKEN FINGER FLANGES                 Provide the exact location of the breakage on the syringe? "NEAR THE PLUNGER WHERE YOU PUT YOUR FINGERS, THE FLANGES"                  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? N/A                    If yes, describe N/A                    If yes, was it supplied by MERCK: N/A                    If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A  Under what situation was this defect noticed: (select one) THE CALLER "NOTICED THE DEFECT IMMEDIATELY UPON UNPACKING EVERYTHING FROM SHIPPING CONTAINER"         While the syringe was still in the tray? YES ONE WAS BENT BOX AND PIECES "FLOATING THERE"                  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 "THERE ARE PIECES OF FLOATING GLASS IN THE TRAY"          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? N/A          If no, describe issue:  Was the syringe tray intact and undamaged on receipt? NO         If no, describe damage. CARTON WAS "BENT". CALLER STATED THERE WERE NO OTHER DEFECTS  If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  *See below. N/A "NO CELLOPHANE COVER"         If no, describe damage  Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) YES, "IT WAS BENT" The CALLER SPECIFIED NO OTHER DAMAGE WAS NOTICED TO THE BOX,           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: N/A  *If photos are available, ask the customer to send   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:  29-AUG-2022 15:30:QUESTION SECTION:   IF REPORTED: Damaged &/or Defective Product Cartons (e.g. flaps coming open) (Medium Risk)  What type of carton is damaged? (e.g. single vial, 10x carton, syringe carton etc.): SYRINGE  Please describe in detail the defect or damage to the carton?  (e.g., ripped, unglued, cut with knife, flaps out): BOX WAS BENT  If the glued sides of the product carton have partially or completely opened: N/A          Is there any evidence of glue? NA          How many dots of glue are present on the carton? NA          Does it look like it has been ripped open? (i.e. torn paper stuck to areas of glue?) NO (describe)  Was there any exposure to moisture (including temperature excursions that could have led to moisture exposure) during shipment &/or storage? UNSPECIFIED What was inside the carton? (e.g., PI, 10 vials - list all contents & quantity) TWO PACKS OF 5 SYRINGES OF hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). TWO SYRINGES WERE DAMAGED   Was any damage noticed to the carton's contents?  YES          If there is any damage to the contacts, such as broken, missing flip cap etc... please also refer to appropriate article for other defects reported to report that PQC. YES, TWO BROKEN SYRINGES  When was the defect noted (on arrival of the shipment? After storage?) (specify) AFTER OPENING THE SHIPPING CONTAINER TO STORE THE PRODUCTS         If the defect was not noticed until after storage, where was the product stored? PRODUCTS WERE NOT STORED N/A  Was the outer shipping carton intact and sealed on delivery? YES         If no, describe any damage.  What was the condition of the contents upon arrival? (e.g. packed tightly and undamaged, in disarray with contents out of the carton etc...) (Describe in detail).  TWO BROKEN SYRINGES, NO OTHER DAMAGED OR COMPLAINTS NOTED   (When applicable) Were the ice packs still frozen and in place? YES/NO/UNSPECIFIED (describe) UNSPECIFIED  *If pictures may help, ask the customer to send them  Retrieval Information: Retrieve product. For 10x carton contact Quality with the lot # and verify the retrieval site.  ATTACHMENT SECTION:  Addl Info. Product Retrieval Process Guide  29-AUG-2022 15:30: Attachment added.  29-AUG-2022 15:30: Attachment added.  29-AUG-2022 15:30: Email received in the mailbox on 29-AUG-2022 at 12:37 with pictures associated with this case. See attachment.  29-AUG-2022 Anonymized; Received & Attached Photos. 29-AUG-2022 Anonymized: Based on the review of the PQC the priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table. 29-AUG-2022; Second person reviewed by Anonymized  30-AUG-2022 12:30: Waiting for Retrieval Site from Quality--- See attachments  30-AUG-2022 12:30: Attachment added.   Complaint Description Summary The caller stated that she noticed the box of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was "bent" and 2 broken syringe.