Sex: U
Vaccine: HPV9
Symptoms: Device breakage, Syringe issue
Clinical narrative: laceration of thumb; injury associated with device; 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 referred to a healthcare professional of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided.  On 20-JAN-2023, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccines (yeast) (GARDASIL 9) injection (lot #U039529, expiration date: 09-AUG-2024) was cracking either during administration or when pushing out the air. The crack was at "glass rim part" in the area near the syringe finger flanges (syringe issue). The administering healthcare professional might have gotten cut on the thumb (injury associated with device, skin laceration). The outcome of the event was unknown.  The causal relationship between cut on the thumb and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  This is one of the two reports received from the same reporter.  This report is non-valid due to no patient identifier.   Follow-up information was received from a medical assistant on 03-MAR-2023. A picture of broken part of the syringe was received.  Complaint Description Detail 381930 was created as the updated information received on 22-FEB-2023, as the 3 syringes have unknown lots and 380355 will capture the information of known Lot# U039529. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. 02-FEB-2023 16:30 PM: Agent made outbound call attempt to reach medical assistant. Voicemail was left with 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 Cloud. 03-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. As the location of the defect is unknown (either syringe hub or syringe barrel), both the sites (manufacturing and packaging) have been selected. Post confirmation received from DPOC, record will be updated accordingly. Notification has been sent to DPOC to confirm, 1. Exact location of defect (crack). 2. Lot number. 3. Complaint product photographs. 03-FEB-2023: Second person review completed. 03-FEB-2023 12:30 PM: Attachment added to Cloud. 03-FEB-2023 12:30 PM: Email received in PQC Mailbox on 03-FEB-2023 at 11:15 am with the following request from Quality: "Acknowledged receipt of this PQC. - Please confirm the exact location of defect (crack). - To confirm Lot number. - To provide photographs." See attached. Forwarded to case owner for follow up. 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. 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 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 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, 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." 08-FEB-2023: The updated information received through interface from the DPOC: The field Complaint Description Detail has been appended to: Outbound call was made to medical assistant. Medical assistant states she is still gathering details regarding the issue and will follow up 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, 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." Mail communication has been attached in the reference tab. - will be notified about the same. 13-FEB-2023 - The operations team has reviewed this record and confirmed that the partner has not released any final product to the market at this time. As a result this site identified on the product supply chain map as a potential investigating site is not valid at this time. Will be cancelling this investigation and removed as a potential lead from this investigation for the unknown lot product. 17-FEB-2023 13:30 PM: Attachment added to Cloud. 17-FEB-2023 13:31 PM: Email received in the PQC Mailbox on 17-FEB-2023 at 9:15am with the following request from quality: "Please confirm the following: 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." See attachment. Forwarded to case owner for follow up. 20-FEB-2023; Acknowledgement received. 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: NO new information has been received in this interphase update, so was not notified about that, If any update is received all the will be notified about the same. 22-FEB-2023 13:30 PM: Outbound attempt made to medical assistant to collect requested details from Quality. Voicemail was left with 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- 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. No additional AEs or PQCs reported. 24-FEB-2023: As per additional information received on 22-FEB-2023 in response to request sent in 380355, clinic stated that they has "had at least 3 to 4 incidents with GARDASIL HPV vaccine cracking either during administration or when pushing out the air and they 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 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 the 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." - The Lead has been notified about the lot number updated in the record and the other remaining sites are informed that they have been removed from the investigation as per the update received on 22-FEB-2023. 24-FEB-2023: Second person review completed for lot number Manufacturing Site change. 24-FEB-2023: Based on the information provided above and the reported lot # not being associated with Merck will cancel the assigned PQC.  03-MAR-2023: Notification has been sent to DPOC to follow up if any information can be obtained on this record. 03-MAR-2023 13:30 PM: Agent made outbound call attempt to reach medical assistant. Voicemail was left with 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 Cloud. 03-MAR-2023 14:30 PM: Email received in the Contact Center mailbox on 03-MAR-2023 at 1:23 pm with pictures associated with this case. See attachment. 06-MAR-2023: Based upon the updated information and image received from DPOC on 03-MAR-2023, the following changes have been made in the record: - Product complaint category was updated from Cracked syringe to Broken Syringe>>Broken During or After injection. - Complaint Description Summary was also updated "Based upon the updated image received, finger flange was broken." Based upon the information received. - The Device reportability Tab was also updated. - Priority will remain same as High. - will remain same. - Notification was sent to regarding the update received. 07-MAR-2023: Second person review completed. 06-MAR-2023 16:31 PM: Attachment added to Cloud. 06-MAR-2023 16:31 PM: Email received in the 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 381930 as has asked DPOC 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. ; Sender's Comments:  US-009507513-2303USA000677:Same Reporter