Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;N/A;Broken Syringe; Complaint Description Detail  Office manager reported that her facility received a carton of ten pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringes. Immediately upon opening carton, office manager noticed that one of the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringes was damaged. The pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringe was intact, but the finger flange was broken and sliding up and down the lime green plunger. Office manager confirmed that product had not been administered to patient. Office manager confirmed that syringe itself was not broken, and no product had leaked. One of the ten pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringes were effected. Office manager confirmed that the other nine were undamaged. See request case: 02199095. No AE reported. No additional PQC reported.  QUESTION SECTION:   Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Immediately upon opening carton, office manager noticed that one of the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringes was damaged. The pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringe was intact, but the finger flange was broken and sliding up and down the lime green plunger.  Notes for DPOC:  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 Was there a crack? No.                 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 Was the syringe broken into 2 or more pieces? No. The syringe was intact, the finger flange was broken and sliding up and down the lime green plunger.                  o If yes, describe in detail how it was broken: (e.g. shattered, broken in half etc.) N/A                 o Provide the exact location of the breakage on the syringe? N/A          o Does the syringe have a broken component? Yes. Loose/broken finger flange.                 o If yes, describe in detail how it was broken. The finger flange broke off, and was sliding up and down the lime green plunger.                  o Provide the exact location of the breakage on the syringe? The plastic ring broke and was separated from the pre filled syringe vaccine. It broke right at the bottom of the body of the pre filled syringe.                 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? N/A. A needle had not been attached.                     o If yes, describe. N/A.                     o If yes, was it supplied by MERCK: N/A.                     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? YES.                 o If yes, was there product (liquid or dried residue) in the tray? No.                 o Was there any broken glass or other separated component in the tray? (if yes specify) No.          o After removing the syringe from the tray? N/A         o While trying to attach the needle to the syringe? N/A          o While giving the injection? N/A          o Immediately after giving the injection? N/A  o Was the syringe tip cap attached properly prior to use? N/A  o Was the syringe tray intact and undamaged on receipt? Yes.  o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? Yes.  o Was the syringe carton damaged prior to use? No.  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? No.  o If complaint sample was not/could not be returned, please provide reason.  06-JUL-2022 16:30 PM: Attachment added.  06-JUL-2022 16:30 PM: Email received in the Mailbox on 06JUL2022 at 12:46pm with pictures for this case. See attached.  06-JUL-2022 16:30 PM: Attachment added.  07-JUL-2022: Received & attached Photos.  07-JUL-2022: Second person review.  07-JUL-2022 13:30 PM: Attachment added.  07-JUL-2022 13:30 PM: Email received in the Mailbox on 7-JUL-2022 at 9:29am from quality stating: "Route return expediated mailer to manufacturing site". See attached. Email forwarded to the mail team.  07-JUL-2022 15:30 PM: Labels created for manufacturing site. 07-JUL-2022