Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: No additional AE/PQC reported.; Sterile Injectable;Broken;Syringe Hub Defect; HCP reported that when she tried the screw the needle to pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) syringe, the neck of the syringe "snapped off". Agent filed AE as FYI potential exposure to drug. Precautionary AE filed. No additional AE/PQC reported. No further information was provided. Mailer sent for product retrieval.  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:                 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.): CALLER SAID WHEN SHE TRIED TO ATTACH THE NEEDLE TO THE SYRINGE, THE NECK OF THE SYRINGE SNAPPED OFF                 o Provide the exact location of the breakage on the syringe?            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: THE NECK OF THE SYRINGE, WHERE NEEDLE IS ATTCHED IS BROKEN                 o Provide the exact location of the breakage on the syringe? NECK                  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? 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? NO                 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? NA          o While trying to attach the needle to the syringe? YES           o While giving the injection? NA           o Immediately after giving the injection? NA  o Was the syringe tip cap attached properly prior to use? NA          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. YES         o If no, describe damage  o Was the syringe carton damaged prior to use?  NO          o If yes, describe  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NA  o If complaint sample is not/cannot be returned, please provide reason:   *If photos are available, ask the customer to send them; CALLER SAID SHE CAN'T TAKE PICTURES BECAUSE PHARMACY DOES NOT ALLOW TO TAKE PICTURES WHILE AT WORK WITH THEIR CELL PHONES  Retrieval Information:  o Obtain product (& tray if possible); CALLER SAID SHE WLL SEND THE DEFECTIVE SYRINGE BACK WHEN SHE RECEIVES THE MAILER, (inconsistent information: Sample Expected field also reported as No) 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:  21-SEP-2022 11:30 AM: Attachment added.  21-SEP-2022 11:30 AM: Attachment added.  21-SEP-2022: Requested route mailer and obtain photos if possible.  21-SEP-2022 Based on the review of the PQC the priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table.  21-SEP-2022 12:30 PM: Please ignore the sentence "AE filed" in the case details. It was added in error to this case.  21-SEP-2022: Second person review performed  21-SEP-2022 15:30 PM: Email received in the Contact Center Mailbox on 21-SEP-2022 at 1:06pm from quality stating: "Please obtain photos if possible and route return mailer." See attached. Email forwarded to case owner for further follow up.  21-SEP-2022 15:30 PM: Attachment added.  21-SEP-2022 15:30 PM: Attachment added.  21-SEP-2022 15:30 PM: Email received in the PQC Mailbox on 21-SEP-2022 at 1:40pm from quality stating: "Please disregard previous email regarding retrieval site. This case needs to be rerouted." See attached. Email forwarded to mail team for further handling.  21-SEP-2022 15:30 PM: CORRECTION: Email received on 21-SEP-2022 at 1:06pm was received in the PQC Mailbox  21-SEP-2022 16:30 PM: Please see note where caller said she will not be able to send pictures. Caller said she can't take pictures because pharmacy does not allow them to take pictures with their cell phones.  22-SEP-2022 14:30 PM: Labels created