Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: Sterile Injectable;Broken / Cracked / Damaged Luer Lock;Syringe Hub Defect; no adverse event; agent transferred from specialist stating a shipment of VAXNEUVANCE arrived with the Leuer lock portion of the syringe damaged. Caller stated she will send pictures and can return. Initially determined to be damaged shipment since it arrived to the pharmacy that way but PQC filed so product can be returned. She stated this is the second time in a month that product arrived damaged. Previous case filed under 02229253. No additional PQC details or AE.  QUESTION SECTION:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for DPOC:  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: UNSPECIFIED                 o Provide the exact location of the crack on the syringe: UNSPECIFIED         o Is the syringe broken into 2 or more pieces? UNSPECIFIED                 o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) UNSPECIFIED                 o Provide the exact location of the breakage on the syringe?  UNSPECIFIED          o Does the syringe have a broken component? UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange)                 o If yes, describe in detail how it is broken. UNSPECIFIED                 o Provide the exact location of the breakage on the syringe? LUER LOCK                 o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES         o Was there difficulty trying to attach the syringe needle to the syringe? NO                    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? YES                 o If yes, is there product (liquid or dried residue) in the tray? UNSPECIFIED                 o Is there any broken glass or other separated component in the tray? (if yes specify) UNSPECIFIED          o After removing the syringe from the tray? UNSPECIFIED          o While trying to attach the needle to the syringe? UNSPECIFIED           o While giving the injection? NSPECIFIED           o Immediately after giving the injection? UNSPECIFIED  o Was the syringe tip cap attached properly prior to use? UNSPECIFIED          o If no, describe issue: UNSPECIFIED  o Was the syringe tray intact and undamaged on receipt? /UNSPECIFIED         o If no, describe damage. UNSPECIFIED  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 UNSPECIFIED  o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNSPECIFIED           o If yes, describe UNSPECIFIED  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? UNSPECIFIED  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:  08-SEP-2022 11:30 AM :Attachment added.  08-SEP-2022: Requested provide correct reference case number for the product that arrived damaged the first time since it appears case filed under 02229253 corresponds with a vial of STERILE DILUENT with flip a dislodged cap.  08-SEP-2022: Informed   08-SEP-2022: Second person reviewed  08-SEP-2022: Attachment added.  08-SEP-2022 14:30 PM :Email received on 08-SEP-2022 at 12:07pm from quality stating: "Please provide correct reference case number for the product that arrived damaged the first time since it appears case filed under 02229253 corresponds with a vial of STERILE DILUENT with flip a dislodged cap." Email forwarded to case owner for further handling. See attached.  08-SEP-2022 14:31 PM :Email received on 8-SEP-2022 at 12:07pm from quality stating: "Please provide correct reference case number for the product that arrived damaged the first time since it appears case filed under 02229253 corresponds with a vial of STERILE DILUENT with flip a dislodged cap." Email forwarded to case owner for further handling. See attached.  08-SEP-2022 14:31 PM :Attachment added.  08-SEP-2022 14:31 PM :Email received on 8-SEP-2022 at 12:11pm from quality stating: " Email forwarded to mail team for further handling. See attached.  08-SEP-2022 15:30 PM :The case number in the description is the correct case 02229253. This was not the same product but she stated she had to submit 2 PQCs in the last month.  08-SEP-2022 15:30 PM :Waiting for Retrieval Site from Quality--See attachments  08-SEP-2022 15:30 PM :Attachment added.  09-SEP-2022 12:30 PM :Labels created 09/09/2022   09-SEP-2022: Requested confirm that this case 02242220 is the second time she referred to as "the second time in a month that product arrived damaged" and 02229253 (Sterile Diluent) was the first time.  09-SEP-2022 16:30 PM :Attachment added to Service Cloud.  09-SEP-2022 16:30 PM :Email received on 09Sep2022 at 1:24pm with request from Quality: "Please confirm that is the second time she referred to as "the second time in a month that product arrived damaged" and 02229253 (Sterile Diluent) was the first time." See attached. Forwarded to case owner for follow up.  12-SEP-2022 12:30 PM :Quality clarification: During the call that was taken for case 02242246, the caller had mentioned calling earlier "within the past month" she had called in a PQC. The PQC was identified as case 02229253 in which the caller had called in a PQC on DILUENT making case 02229253 the first time and case 02242246 the second time. To provide further clarification, a voicemail was left for the customer with phone number, hours of operation, and case number. If callback received, please confirm that the previous PQC the caller mentioned during call for case 02242246 (VAXNUEVANCE) was in fact case 02229253 which was for DILUENT.  12-SEP-2022: Based on further review and concurrence with suggestion both the Reported & Investigative PQC Catagories for Complaint Category Details were updated to Broken/Cracked/Damaged Luer Lock  12-SEP-2022; Second person review  13-SEP-2022 11:30 AM :Inbound call from customer in interaction 02245682. She confirmed that the two times she has received damaged product were the current case, 02242246 (VAXNEUVANCE) and the prior call which was identified as case 02229253 (sterile diluent). She confirmed case numbers and products were correct for the two cases she reported. No additional information was provided; no additional PQC/no AE.