Sex: U
Vaccine: PNC15, PNC15
Symptoms: Syringe issue
Clinical narrative: no adverse event; 2 VAXNEUVANCE PFS found broken when tray opened; Caller reported 2 pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE PFS) found broken when tray opened.  No AE reported.  No additional PQC reported.  Caller will send picture and will hold product and tray for return.  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? NO                 o If yes, describe the size, shape & depth of the crack: NA                 o Provide the exact location of the crack on the syringe: NA         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.)                           Leur-lock is broken off                 o Provide the exact location of the breakage on the syringe?   Leur-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. Leur-lock is broken off                 o Provide the exact location of the breakage on the syringe? Leur-lock                 o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES (if yes describe)          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?'NA  o Under what situation was this defect noticed: (select one)         o While the syringe was still in the tray? YES                 o If yes, is there product (liquid or dried residue) in the tray? NO                 o Is there any broken glass or other separated component in the tray? (if yes specify) Yes- Leur-lock is separated          o After removing the syringe from the tray? NO         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? YES          o If no, describe issue: NA  o Was the syringe tray intact and undamaged on receipt? YES         o If no, describe damage. NA  o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  *See below. YES         o If no, describe damage NA  o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) NO          o If yes, describe NA  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:  NA  *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:  20-JUL-2022 15:30 PM :Attachment added to Service Cloud.  20-JUL-2022 15:30 PM :Attachment added to Service Cloud.  20-JUL-2022 15:30 PM :Email received on 20-JUL-2022 at 2:26pm with pictures related to this case. See attached.  20-JUL-2022: The priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table.    20-JUL-2022: PHOTOS received & attached  20-JUL-2022; Second person reviewed   20-JUL-2022 16:30 PM :Waiting for Retrieval Site from Quality---See attachments  20-JUL-2022 16:30 PM :Attachment added to Service Cloud.  20-JUL-2022 17:30 PM :Attachment added to Service Cloud.  20-JUL-2022 17:30 PM : Labels created   20-JUL-2022    21-JUL-2022 09:30 AM :Attachment added to Service Cloud.  21-JUL-2022: Lead was updated  21-JUL-2022;  Second reviewed   21-JUL-2022: Requested reroute return mailer  21-JUL-2022 13:30 PM :Attachment added to Service Cloud.  21-JUL-2022 13:30 PM :Email received on 21-JUL-2022 at 12:05pm with the following request from quality: "Please reroute return mailer." Forwarded to mail team for follow up. See attached.  21-JUL-2022 15:30 PM :Attachment added  21-JUL-2022 15:30 PM : Labels created