Sex: U
Vaccine: HEPA
Symptoms: Needle issue, No adverse event, Syringe issue
Clinical narrative: No AE; Sterile Injectable;N/A;Broken Syringe; Complaint description detail  Medical assistant calling to report a quality complaint with VAQTA. She states that a staff member went to pull a vaccine out of the refrigerator and noticed that the finger flange of 1 syringe of VAQTA was cleanly broken off in 1 piece. She states that the CMA set the VAQTA aside and after inspection the vaccine and broken finger flange piece was discarded. Customer states that the vaccine is not available for return and they did not take pictures of the product prior to discarding. The customer declines replacement/credit. No AE. No additional PQC. No additional information.  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                 If yes, describe the size, shape & depth of the crack: The entire finger flange broken off in 1 piece, no cracks anywhere else on the syringe                  Provide the exact location of the crack on the syringe: the entire finger flange broke off in 1 piece          Is the syringe broken into 2 or more pieces? No                 If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) NA                 Provide the exact location of the breakage on the syringe?  Finger flange broken off in 1 piece           Does the syringe have a broken component? Yes (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange)                 If yes, describe in detail how it is broken. Finger flange broken completely off in 1 piece                  Provide the exact location of the breakage on the syringe? Finger flange broken completely off in 1 piece                  Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? No (if yes describe)          Was there difficulty trying to attach the syringe needle to the syringe? The cap was still securely on, the customer did not attempt to attach syringe needle                     If yes, describe NA                    If yes, was it supplied by MERCK: NA                    If not supplied by MERCK, what type & brand, needle size & gauge was used?' NA  Under what situation was this defect noticed: (select one)         While the syringe was still in the tray? Yes, she did take it out of the tray to inspect and then placed it to the side after noticing broken flange.                  If yes, is there product (liquid or dried residue) in the tray? No                  Is there any broken glass or other separated component in the tray? (if yes specify) Yes, finger flange broken in 1 piece           After removing the syringe from the tray? Yes          While trying to attach the needle to the syringe?  The cap was still securely on, the customer did not attempt to attach syringe needle            While giving the injection? The cap was still securely on, the customer did not attempt to attach syringe needle. Vaccine was never given to a patient.          Immediately after giving the injection? The cap was still securely on, the customer did not attempt to attach syringe needle. Vaccine was never given to a patient.  Was the syringe tip cap attached properly prior to use? Yes          If no, describe issue:  Was the syringe tray intact and undamaged on receipt? Yes         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         If no, describe damage  Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued)  No          If yes, describe  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? No  If complaint sample is not/cannot be returned, please provide reason: Customer discarded vaccine and broken off finger flange, sample is not able to be returned.   *If photos are available, ask the customer to send them to Merck Customer discarded vaccine and broken off finger flange, sample is not able to be returned.   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:  20-JUL-2022 11:30 AM :Update applied, refer to RA  20-JUL-2022  Second person reviewed  21-JUL-2022 Received & a Attached document email sent to RA.