Sex: U
Vaccine: PNC15, PNC15
Symptoms: Device issue, Syringe issue
Clinical narrative: Sterile Injectable;Broken;Syringe Hub Defect; no adverse event; Field employee called to report a PQC in behalf of a medical assistant. The medical assistant told the field employee that 2 prefill pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) syringes were "sheared off" at the tip of the syringe where Luer Lock meets the body of the syringe. They were broken off while needles were being attached. Both syringes were from the same lot but she was not sure if they were from the same tray. Both of the broken syringes were discarded so no products can be returned to Merck.  Please see attachments for the photos. No AE. 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:  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? UNSPECIFIED                 o If yes, describe the size, shape & depth of the crack:                 o Provide the exact location of the crack on the syringe:         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.) IT WAS SHEARED OFF.                  o Provide the exact location of the breakage on the syringe? BETWEEN THE BARREL AND LUER LOCK.            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.                     o Provide the exact location of the breakage on the syringe? BETWEEN THE BARREL AND LUER LOCK.                   o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES (if yes describe) BROKEN OFF OF THE SYRINGE TIP          o Was there difficulty trying to attach the syringe needle to the syringe? NO                    o If yes, describe                    o If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED                    o If not supplied by MERCK, what type & brand, needle size & gauge was used?'  o Under what situation was this defect noticed: (select one)           o While the syringe was still in the tray? YES/NO/NA/UNSPECIFIED                 o If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED                 o Is there any broken glass or other separated component in the tray? (if yes specify)          o After removing the syringe from the tray? YES/NO/NA/UNSPECIFIED          o While trying to attach the needle to the syringe? YES           o While giving the injection? YES/NO/NA/UNSPECIFIED           o Immediately after giving the injection? YES/NO/NA/UNSPECIFIED  o Was the syringe tip cap attached properly prior to use? UNSPECIFIED          o If no, describe issue:  o Was the syringe tray intact and undamaged on receipt? YES         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. UNSPECIFIED         o If no, describe damage  o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNSPECIFIED           o If yes, describe  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: CANNOT BE RETURNED BECAUSE THEY WERE 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. 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:  11-MAY-2022 19:30 PM :Attachment added to Service Cloud.  11-MAY-2022 19:30 PM :Attachment added to Service Cloud.  11-MAY-2022 19:30 PM :Attachment added to Service Cloud.  11-MAY-2022 19:30 PM :Attachment added to Service Cloud.  11-MAY-2022 19:30 PM :Attachment added to Service Cloud.  12-MAY-2022: Received & Attached photos. 12-MAY-2022;  Second person reviewed  12-MAY-2022: Procode field updated to reflect upon confirmation.