Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;N/A;Broken SyringeSterile Injectable;N/A;Cracked Syringe; Sterile Injectable;N/A;Broken SyringeSterile Injectable;N/A;Cracked Syringe; Email received in the Mailbox on 09-AUG-2022 at 2:40 pm with an attachment reporting 3 PQC's with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). "2nd Incident" filed within this case. All other PQC's reported within this email handled appropriately. See case notes for more information. Outbound call placed to customer; however, customer did not answer so filing with limited information at this time. It is reported in the email that the box was discarded; therefore, the "obtain" box will be left unchecked as product cannot be obtained. Some questions marked "unknown" as they were unable to be asked. HCP demographics were not provided so no letter sent. No AE reported. See attached.   PQC: "2nd incident: Last week an LVN had to through out a whole box of 10 syringes all were damaged. (unfortunately I just heard about it. Box discarded)"  The PQC article attached was used as it is unknown at this time what the customer meant by "damaged." Attachment added. 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:  09-AUG-2022 at 19:30: Case 02060951 = Original HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) PQC reported; Case 02151379 = Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) PQC mentioned in attached email chain on 18-APR-2022 at 15:43; Case 02151454 = Miscellaneous product mentioned in attached email chain on 18-APR-2022 at 15:43; Case 02222329 = Incident 1 PQC reported in word documented attached to email; Case 02222255 = Incident 2 PQC reported in word documented attached to email; Case 02222256 = Incident 3 PQC reported in word documented attached to email.  09-AUG-2022 19:30: Outbound call placed to customer. Voicemail left with phone number and case number. All PQC details need to be collected from customer as limited information was provided within the email.  09-AUG-2022 19:30:Outbound call placed to the reporter. He reported that he has no additional information and to contact another reporter. See below note where outbound call was placed to new reporter.  09-AUG-2022 19:30: QUESTION SECTION:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for DPOC:  o 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. o 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).  o Please provide a detailed description of the defect using the questions below:        o Is there a crack? UNKNOWN                 o If yes, describe the size, shape & depth of the crack: UNKNOWN                 o Provide the exact location of the crack on the syringe: UNKNOWN         o Is the syringe broken into 2 or more pieces? UNKNOWN                 o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.)                 o Provide the exact location of the breakage on the syringe?  UNKNOWN          o Does the syringe have a broken component? UNKNOWN (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange)                 o If yes, describe in detail how it is broken. UNKNOWN                 o Provide the exact location of the breakage on the syringe? UNKNOWN                 o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? UNKNOWN (if yes describe)          o Was there difficulty trying to attach the syringe needle to the syringe? UNKNOWN                    o If yes, describe                    o If yes, was it supplied by MERCK: UNKNOWN                    o If not supplied by MERCK, what type & brand, needle size & gauge was used?' UNKNOWN  o Under what situation was this defect noticed: (select one)         o While the syringe was still in the tray? UNKNOWN                 o If yes, is there product (liquid or dried residue) in the tray? UNKNOWN                 o Is there any broken glass or other separated component in the tray? (if yes specify) UNKNOWN          o After removing the syringe from the tray? UNKNOWN          o While trying to attach the needle to the syringe? UNKNOWN           o While giving the injection? UNKNOWN           o Immediately after giving the injection? UNKNOWN  o Was the syringe tip cap attached properly prior to use? UNKNOWN          o If no, describe issue:  o Was the syringe tray intact and undamaged on receipt? UNKNOWN         o If no, describe damage.  o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  *See below. UNKNOWN         o If no, describe damage  o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNKNOWN          o If yes, describe  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? UNKNOWN  o If complaint sample is not/cannot be returned, please provide reason: PER THE EMAIL, "BOX DISCARDED"   *If photos are available, ask the customer to send them  Retrieval Information:  o Obtain product (& tray if possible) o 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.  10-AUG-2022: Requested clarify what does "damaged" mean?  10-AUG-2022: Reported lot U032636 logged under 368084 & 1st incident from unknown lot logged under 368086  10-AUG-2022 17:30: Attachment added.  10-AUG-2022 17:30: Email received in the Mailbox on 10-AUG-2022 at 4:40PM with the following request from Quality: "Please clarify with reporter, what does "damaged" mean?" See attached. Forwarded to case owner for follow up.  10-AUG-2022 17:30: Outbound call was placed to customer to clarify what "damaged" means as well as to collect all additional PQC details. Voicemail left for customer to call. Will provide additional follow up information when customer is able to be contacted.  10-AUG-2022: email containing correspondence and PHOTOS received & attached  10-AUG-2022: Requested clarify word document attachment from reporter dated 09-AUG-2022 - for photos provided in this email what case do they correspond with and can lot numbers be obtained for images in pages 4,5,6 and 7.  11-AUG-2022 11:30: Attachment added.  11-AUG-2022 11:30: Email received in the Mailbox on 10-AUG-2022 at 18:14 from quality stating: "Clarification requested on word document attachment from reporter dated 09-AUG2022 - for photos provided in this email what case do they correspond with and can lot numbers be obtained for images in pages 4,5,6 and 7." See attached. Email forwarded to case owner for follow up.  11-AUG-2022 11:30: The photos provided in the word document attachment are associated with case 02222256 and that is documented within the description of that case. See notes within that case for additional information pertaining to the lot/expiration from the photos.  11-AUG-2022: Requested confirm if there are two syringes or if the two photos are from the same syringe from lot 1780878 based on photos provided by reporter.  11-AUG-2022 12:30: Attachment added.  11-AUG-2022 12:30: Email received in Mailbox on 11-AUG-2022 at 11:14 with the following request from Quality: "Appears in the photos provided by the reporter that there are two broken syringes from lot 1780878. Please confirm if there are two syringes or if the two photos are from the same syringe." See attached. Forwarded to case owner for follow up.  11-AUG-2022 12:30: Correction: Agent added attachment to wrong case. This will be added to the proper case under the same interaction.  11-AUG-2022 12:30: 2nd Outbound call placed to customer. Voicemail left with phone number and Interaction number for all relevant cases. When customer calls back, all PQC details will be collected. Until contact is made with the customer, no further information is available.  15-AUG-2022 15:30: 3rd Outbound call placed to customer. Voicemail left with phone number and Interaction number for all relevant cases. When customer calls back, all PQC details will be collected. Until contact is made with the customer, no further information is available.  15-AUG-2022 16:30: Inbound call received from customer. The customer reports that this incident was already reported to his coordinator. It was reported to him that when a box of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringes were initially opened, it was noted that all of the syringes were either cracked, broken, or damaged in some way. He does not have specific details about the "damage." He does not know if the primary box was damaged as he reports that he does not unpackage the products. He reports that this is the only information he has on the incident and declines further contact. He reports that the products were all discarded and are not available to return. He reports that he received this information second hand and cannot provide any additional information or answer any other questions.  16-AUG-2022; Second person reviewed.  16-AUG-2022: Lot 1780878 logged under 368084 & lot U032636 logged under 368086  16-AUG-2022 13:30:Update applied, refer ; Sender's Comments: Onset Date: "Last Week" US-009507513-2208USA005510: US-009507513-2111USA008646: US-009507513-2111USA009249: US-009507513-2204USA007742: US-009507513-2208USA004763: US-009507513-2208USA004770: US-009507513-2208USA006616: