Sex: U
Vaccine: HPV9
Symptoms: Needle issue
Clinical narrative: Full AE filed due to them  using the GARDSIL 9 and it breaking while they were using on a patient caller did not report any other issues; when they open a new package of GARDASIL9 and it always seems that the actually syringes in the packaging are always loose. Caller reported it always seems like the syringes are out of place like the holder itself is not holding them in place; GARDASIL 9 syringe flange broke into 3 different pieces; no adverse event; Complaint Description Detail Per caller he thinks this PQC was called in already but caller did not have case to reference. Caller reported he can send a picture from this issues where the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe flange broke into 3 different pieces. Patient did not miss dose. It happened while in us and being given to patient. Caller mentioned that they have this issue often with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) breaking or cracking. This case is being filed due to not being able to fine original case.  AE & PQC 02268087.  Product no able to be sent back.  LOT: Unknown by reporter EXP: Unknown by reporter  "Per caller when they open a new package of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and it always seems that the actually syringes in the packaging are always loose. Caller reported it always seems like the syringes are out of place like the holder itself is not holding them in place. Caller thinks that maybe why they are having so many syringes break." Full AE filed due to them using the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and it breaking while they were using on a patient caller did not report any other issues or concerns with the patient.   QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.   Notes for RA:  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 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. 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:  14-OCT-2022 16:30: Attachment added to Service Cloud.  14-OCT-2022 16:30: Email received in the Service Center Mailbox on 14-OCT-2022 at 12:16 with photos from the customer of this case. See attached. 14-OCT-2022: Company Employee - Requested obtain the complete lot number from the photo.  14-OCT-2022 18:30: Attachment added to Service Cloud.  14-OCT-2022 18:30: Email received in the PQC Mailbox on 14-OCT-2022 16:57 from QUALITY"Pls. obtain the complete lot number from the photo provided." See attached. Forwarded to case owner for follow up. 17-OCT-2022: Company Employee - PHOTO received & attached 17-OCT-2022: Company Employee - Based on attached photo received stating "I was giving a HPV vaccine today and the bottom glass part broke and cut my finger. I was able to give the full dose. The lot number is U031056." 17-OCT-2022: Company Employee NOTE: Unknown lots for reported issues where "Caller mentioned that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) breaking or cracking" logged under PR 372903. 17-OCT-2022: Second person reviewed by Reviewer 1 18-OCT-2022 17:30: Attachment added to Service Cloud. 18-OCT-2022 17:30: Attachment added to Service Cloud. 18-OCT-2022 17:30: Email received in the PQC Mailbox on 18-OCT-2022 at 15:53 with the following message from Specialist, Quality Assurance with the following message from quality: "The Investigator has a few clarifying questions surrounding the two complaint PQC's entered on 14-OCT-2022. Please review and follow-up with customer. 1. Why does PQC 372903 have complaint category of "Cracked Syringe" selected? 2. Why do PQCs 372897 and 372903 have complaint categories of "Disassembled Upon Opening"? 3. For PQC 372903, can the batch number be confirmed? Was the batch number U031056 which was reported PQC 372897? 4. Can you confirm the number of broken syringes for PQC 372903?" See attachment. Replied to specialist, quality assurance asking for SC case numbers. No additional information.  18-OCT-2022 17:30: Email received in the PQC mailbox on 18-OCT-2022 at 16:18 with a reply from quality stating: "I retrieved information from the records in question and added below in yellow/green." Her responses are included: Why does PQC 372903 have complaint category of "Cracked Syringe" selected? 17-OCT-2022: Company Employee Additional Complaint Category added to Reported & Investigated PQC Categories based on follow up received in case 02268045 (PR 372905) stating "Caller reported he can send a picture from this issue where the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe flange broke into 3 different pieces. Caller mentioned that they have this issue often with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) breaking or cracking". 1. Why do PQCs 372897 and 372903 have complaint categories of "Disassembled Upon Opening"? Per caller when they open a new package of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and it always seems that the actually syringes in the packaging are always loose. Caller reported it always seems like the syringes are out of place like the holder itself is not holding them in place. Caller thinks that maybe why they are having so many syringes break." 2. For PQC 372903, can the batch number be confirmed? Was the batch number U031056 which was reported PQC 372897? PR 372903 was specifically logged for the unknown broken/cracked syringes 3. Can you confirm the number of broken syringes for PQC 372903? This was logged due to the mention of having so many syringes that are broken so 2 is logged for more than one unknown lot, the reported lot they had on hand was reported in 372897 "Per caller when they open a new package of GARDASIL9 and it always seems that the actually syringes in the packaging are always loose. Caller reported it always seems like the syringes are out of place like the holder itself is not holding them in place. Caller thinks that maybe why they are having so many syringes break."' See attachment.  Complaint Description Summary HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe flange broke into 3 different pieces. It happened while in use and being given to patient. ; Sender's Comments:  US-009507513-2210USA005617: