Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: Nurse stating that after GARDASIL 9 was given to a patient and while the syringe was pulling back, the needle detached from the syringe and stayed in the patient's arm; Syringe Hub Defect/ Needle Detached; No additoinal AE; Complaint Description Detail  Field employee called in behalf of nurse who reported possible PQC with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Field employee received an E-mail from the nurse stating that after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given to a patient and while the syringe was pulling back, the needle detached from the syringe and stayed in the patient's arm. The nurse safely removed the needle from the patient's arm. Most questions were answered "Unspecified" because the field employee did not have much information. A call back will be attempted to reach the nurse to obtain the additional information. AE was filed because the patient received the vaccine with PQC issue. No further information was available.  QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes: 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? 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? 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? 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? UNSPECIFIED (if yes describe). Was there difficulty trying to attach the syringe needle to the syringe? UNSPECIFIED If yes, describe If yes, was it supplied by the company: YES/NO/NA/UNSPECIFIED If not supplied by the company, 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 Was the syringe tip cap attached properly prior to use? UNSPECIFIED If no, describe issue: Was the syringe tray intact and undamaged on receipt? 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. UNSPECIFIED If no, describe damage Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) UNSPECIFIED If yes, describe Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES If complaint sample is not/cannot be returned, please provide reason: UNKNOWN *If photos are available, ask the customer to send them to the company 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: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Not Applicable Doubt Details: Not Applicable Migration: Not Applicable Migration Details: Not Applicable Removal Problem: Not Applicable Removal Problem Details: Not Applicable 07-OCT-2022 18:30: Attachment added. 07-OCT-2022 18:30: First call back attempted and left a message. When she calls back, please ask the PQC questions, lot and expiry, and if the product can be retrieved. 07-OCT-2022 18:30: Attachment added. 07-OCT-2022 18:30: Email received in the Mailbox on 7-OCT-2022 at 5:23pm with email correspondence that the field-based employee received. See attached. No additional AE/PQC reported. 07-OCT-2022 18:30: Pictures received within the email received in the Contact Center Mailbox on 07-OCT-2022 at 5:23pm were embedded within the email. Pictures saved within a PDF file and attached separately. See attached. 07-OCT-2022 18:30: Attachment added. 10-OCT-2022: Received & Attached photo. 10-OCT-2022: Requested agency to please ask the reporter, if they can provide the lot number on the syringe as it not clear in the photo provided ? 10-OCT-2022; Second person reviewed 10-OCT-2022 14:30: Second call back attempted and left a message. When she calls back, please ask the PQC questions, lot and expiry, and if the product can be retrieved. 10-OCT-2022 15:30: Attachment added. 10-OCT-2022 15:30:E-mail received in the PQC Mailbox on 10OCT2022 at 9:13am with the following request from quality: "Can you please ask the reporter, if they can provide the lot number on the syringe as it not clear in the photo provided?" See attached. Forwarded to case owner for follow up. 10-OCT-2022 15:30:First call back attempted for clarification from Quality and left a message. If she calls back, please ask for lot and expiry, PQC questions, and if it can be retrieved. No further information was available. 10-OCT-2022 16:30 :Inbound call back from customer regarding this case, before this agent was able to obtain any additional AE or PQC details the call stated that she needed to get off the line and would call back later. Call then abruptly disconnected. No additional AE/PQC. 10-OCT-2022 16:30:Inbound call back from customer regarding this case. Caller states that the nurse that originally reported this AE and PQC is on vacation and that she will provide that nurse with the case number and the number for the agency for call back as she (the caller) does not know the lot number, expiration date or any additional information regarding this AE/PQC. Caller also stated that she was unsure if the product was available for retrieval. No additional AE or PQC details.  Complaint Description Summary Nurse stated that after the HPV RL1 6 11 16 18 31 33 45 52 58 VLP VACCINE (YEAST) (GARDASIL 9) was given to a patient, the syringe was pulling back, the needle detached from the syringe and stayed in the patient's arm.