Sex: U
Vaccine: HEPA
Symptoms: Syringe issue
Clinical narrative: no adverse event; a nurse was removing a VAQTA from it's tray container and notice that it was broken in half; Inbound call from health care professional (HCP) who stated a nurse was removing a Hepatitis A Vaccine, Inactivated (VAQTA) from it's tray container and noticed that it was broken in half. The product was discovered that way and not caused by anyone in the office to the caller's knowledge. No residue, no exposure, and no administration attempted. No additional PQC details or AE. Caller stated they have product for return and would send pictures.  Question section:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes:  o A cracked syringe had a line or chip in the glass, but the syringe was essentially intact in one piece. A syringe was considered broken when the syringe was in 2 or more pieces. o A syringe was also considered "cracked" if it appeared to be intact with evidence of a chip or crack OR appeared to be intact initially but then broke 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? N/A                 o If yes, describe the size, shape & depth of the crack: N/A                 o Provide the exact location of the crack on the syringe: N/A         o Is the syringe broken into 2 or more pieces? YES                 o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) Arrived like this, flange broke into 2 pieces discovered when removing from packaging                 o Provide the exact location of the breakage on the syringe?  Flange          o Does the syringe have a broken component? YES (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? FLANGE                 o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO          o Was there difficulty trying to attach the syringe needle to the syringe? NA                    o If yes, describe NA                    o If yes, was it supplied by MERCK: NA                    o If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A  o Under what situation was this defect noticed: (select one)         o While the syringe was still in the tray? NO                 o If yes, is there product (liquid or dried residue) in the tray? N/A                 o Is there any broken glass or other separated component in the tray? (if yes specify) YES, 2 PIECES OF FLANGE          o After removing the syringe from the tray? YES          o While trying to attach the needle to the syringe? NO           o While giving the injection? NO           o Immediately after giving the injection? NO  o Was the syringe tip cap attached properly prior to use? N/A          o If no, describe issue: N/A  o Was the syringe tray intact and undamaged on receipt? UNSPECIFIED         o If no, describe damage. N/A  o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  *See below. UNSPECIFIED         o If no, describe damage N/A  o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) NO          o If yes, describe N/A  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO  o If complaint sample is not/cannot be returned, please provide reason: N/A  *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. 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:  23-AUG-2022 17:30: Attachment added.  23-AUG-2022 17:30: Email received on 23-AUG-2022 at 16:25 with photos for this case. See attached. No AE or additional PQC reported. No additional information provided.  23-AUG-2022 17:30: Attachment added.  24-AUG-2022: Received & Attached Photos- Employee 1.  24-AUG-2022: Second person review performed by Employee 2  24-AUG-2022: Requested route mailer - Employee 2.  24-AUG-2022 12:30: Attachment added.  24-AUG-2022 12:30: Email received on 24-AUG-2022 at 11:33 from quality stating: "Pls. route return mailer." See attached. Email forwarded to mail team for further handling.  24-AUG-2022 13:30: Email received on 24-AUG-2022 at 11:33 from quality stating: "Pls. route return mailer." See attached. Email forwarded to mail team for further handling.