Sex: U
Vaccine: HPV9
Symptoms: Device breakage, Poor quality device used, Syringe issue
Clinical narrative: GARDASIL HPV vaccine cracking either during administration or when pushing out the air/ crack was at the finger flange; GARDASIL HPV vaccine cracking either during administration or when pushing out the air/ crack was at the finger flange; This spontaneous report was received from medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On unknown dates in 2021, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # and expiry date were not provided), administered for prophylaxis (dose, anatomical locations and route of administration were not provided). During administrations, the syringe cracked at "glass rim part", near the syringe finger flanges (poor quality device used; syringe issue).  This is one of the two reports received from the same reporter.  This report is non-valid due to no patient identifier.  Complaint Description Detail This is a copy record of 380355. As per additional information received on 22-FEB-2023 2023 in response to request sent in PR#380355, clinic stated that they have "had at least 3 to 4 incidents with GARDASIL HPV vaccine cracking either during administration or when pushing out the air and they did not have access to the previous lot numbers as some of the PQC's occurred back in 2021. All other lot numbers are unknown at this time except for PQC-380355 that occurred on 20-JAN-2023 involved lot number U039529 09-AUG-2024 and the crack was at the finger flange. Hence this record 381930 has been created to capture the issue related to 3 syringes belonging to unknown lot number. The company awareness date has been selected as 22-FEB-2023 since the additional information was received on this date. Representative reported that she received an email from medical assistant reporting an issue with multiple GARDASIL 9 prefilled syringes. The email stated the clinic has "had at least 3 to 4 incidents with GARDASIL HPV vaccine cracking either during administration or when pushing out the air." Representative was notified on 01-FEB-2023; she is reporting to the agency today on 02-FEB-2023. Representative explained that she had replied to the medical assistant's email requesting more information but had not heard back. Therefore, no additional information was known related to the event and questions were marked as "Unknown by Reporter." No further information provided. 02-FEB-2023 16:30 PM: Agent made outbound call attempt to reach medical assistant. Voicemail was left with agency phone number and reference case number. UPON CALLBACK, please obtain all information related to "had at least 3 to 4 incidents with GARDASIL HPV vaccine cracking either during administration or when pushing out the air." PQC and AE questions need to be addressed with medical assistant as well as potential for return and photos. 02-FEB-2023 16:30 PM: Attachment added to system. 03-FEB-2023 13:30 PM: Agent made outbound call to reach medical assistant to collect details of AE/PQC. When asked for the exact location of the defect, medical assistant declined it being the barrel or finger flange. She could only describe it as the "glass rim part" and was unable to further clarify. Agency email address was provided to send photos, if available. Lot number was not available at this time. She stated there was "no injury" to any patient but that the administering medical assistant "may have got cut on the thumb." Medical assistant declined to address any further questions, as she was "still collecting details" as the issue had happened multiple times ranging from recently until back to 2021. Medical assistant stated she will contact the agency when she has more information. 03-FEB-2023 13:30 PM: UPON CALLBACK, attempt to narrow down exact location of defect, collect involved lot numbers, and ask probing questions related to event of "had at least 3 to 4 incidents with GARDASIL HPV vaccine cracking either during administration or when pushing out the air." 03-FEB-2023 13:30 PM: Case was reopened to expand Misuse AE to Full Adverse Event due to medical assistant stating the administering HCP "may have got cut on the thumb" during outbound follow up call on 03-FEB-2023. 07-FEB-2023 18:30 PM: Outbound call was made to medical assistant. Medical assistant states she is still gathering details regarding the issue and will follow up with agency when it is available. On this outbound call, she was able to clarify that the "glass rim part" was referring to the area near the syringe finger flanges but not the flange itself. UPON FOLLOW UP WITH agency, collect involved lot numbers, remind her to send photos (if not already received), and ask probing questions related to description of "had at least 3 to 4 incidents with GARDASIL HPV vaccine cracking either during administration or when pushing out the air." 21-FEB-2023 16:30 PM: Agent made outbound call attempt to reach medical assistant to collect requested details from Quality. After waiting on hold for 13+ minutes, agent disconnected; therefore, unable to reach customer or leave voicemail at this time. The following had been requested by Quality: 1. Exact location of defect (crack): As previously documented on 07-FEB-2023, customer reported that the defect was located at "glass rim part" which was further described as the area near the syringe finger flanges but not the flange itself. 2. Lot number: Unable to determine without speaking with customer. 3. Complaint product photographs: Customer was previously instructed during two prior outbound calls to send photos. 4. Whether all the 4 syringes have same lot or different lots: Unable to determine without speaking with customer. UPON CALLBACK, please address questions from Quality. 22-FEB-2023 13:30 PM: Outbound attempt made to medical assistant to collect requested details from Quality. Voicemail was left with agency phone, operating hours, and case number. The following had been requested by Quality: 1. Exact location of defect (crack), 2. Lot number, 3. Complaint product photographs, 4. Whether all the 4 syringes have same lot or different lots: Unable to determine without speaking with customer. UPON CALLBACK, please address questions from Quality. 22-FEB-2023 14:30 PM: Inbound call via interaction 02340224 from- Caller states the PQC that occurred on 20-JAN-2023 involved lot number U039529 09-AUG-2024 and the crack was at the finger flange. Caller states she does not have access to the previous lot numbers as some of the PQC's occurred back in 2021. All other lot numbers are unknown at this time. Caller states she will send a photo of the PFS from the most recent issue on 20-JAN-2023. No other information provided. 24-FEB-2023: Due to the unavailability of lot number, the selection of manufacturing and packaging site has been done by using a supply chain map. 24-FEB-2023: Second person review completed for lot number, E-sign to be performed 03-MAR-2023 10:30 AM: Attachment added to system. 03-MAR-2023 13:30 PM: Agent made outbound call attempt to reach medical assistant. Voicemail was left with agency phone number and reference case number. UPON CALLBACK, please follow up on request from Merck Quality stating: "Can you please provide the complaint sample photographs." 03-MAR-2023 14:30 PM: Attachment added to system. 03-MAR-2023 14:30 PM: Email received in the agency Contact Center mailbox on 03-MAR-2023 at 1:23 pm with pictures associated with this case. See attachment. 06-MAR-2023: Images were received in 380355 where in the finger flange was broken hence that complaint category and was updated accordingly but as there is no clarity received for the events that have been captured under this PQC, the complaint category will remain unchanged. Regulatory authority will be notified to confirm if the same event reported under 380355 of finger flange breaking has occurred with the past events also. As per the response/confirmation received this PQC-381930 will be updated. 07-MAR-2023: Second person review completed. 06-MAR-2023 16:31 PM: Attachment added to system. 06-MAR-2023 16:31 PM: Email received in the agency PQC Mailbox on 06-MAR-2023 at 1:59 PM with the following message from Quality: "Please confirm if the event reported under 380355 of finger flange breaking has occurred with the past events also as reported on 22-FEB-2023 "Caller states she does not have access to the previous lot numbers as some of the PQC's occurred back in 2021." See attached. Forwarded to case owner for follow up. 07-MAR-2023: Notification sent to admin to bring the record in review state. Note: This notification is regarding the PR#381930 as agency has asked agency to clarify if the event reported under 380355 of finger flange breaking has occurred with the past events also as reported on 22-FEB-2023 "Caller states she does not have access to the previous lot numbers as some of the PQC's occurred back in 2021." See attached. Forwarded to case owner for follow up. 07-MAR-2023 12:30 PM: Agent made outbound call to medical assistant to address the following question from Quality: "Please confirm if the event reported under 380355 of finger flange breaking has occurred with the past events also as reported on 22-FEB-2023." Per medical assistant, the past events all involved the finger flange location on the syringe. She stated sometimes a piece of the flange would break completely off and other times it was just a crack at that location. Medical assistant unable to provide any further specifics surrounding prior events. 08-MAR-2023: Update has been received from the agency on 07-MAR-2023 and based upon that information an additional category of "Broken Syringe" needs to be added as complainant reported that for all past events sometimes the finger flange would break off completely, and other times it was just a crack at that location. - Broken Syringe - Broken During or After injection- Was added as it was initially reported that the vaccine cracking occurred either during administration or when pushing the air and some times the finger flange broke completely. - Cracked Syringe- was previously added as complainant reported that sometimes there was crack at the location. -Number of occurrences has been captured as "3" as it was not confirmed from complainant's statement, how many syringes had broken finger flanges and how many were cracked, So 3 will be captured for both. The below changes have been made in the record; - An additional PQC category of Broken Syringe - Broken During or After injection was added. - Priority remained as high. - Number of occurrences remain as 3. - Changes made in Device Reportability Tab as an additional category was added. - agency was notified about the changes made in the record. 09-MAR-2023: Notification was sent to agency Admin to bring the record to 'Awaiting agency review' state for agency 2-day review of the parent record. 08-MAR-2023: Company created a second child record for the new broken syringe defect added on 08-MAR-2023 since the initial lead was closed. ; Sender's Comments:  US-009507513-2302USA001517:same reporter