Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: Medium Risk: Broken Syringe Barrel / CLEAN BREAK NEAR WHERE THE NEEDLE IS ATTACHED / ONE SYRINGE WAS DAMAGED UPON OPENING THE NEW SHIPMENT/PACKAGE; no adverse event; Complaint Description Detail  Calling on behalf of HCP to report that they received a shipment of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) and one of the syringes were broken into two where the needle is attached. Caller reports they can send and picture and the HCP should be hold the product for retrieval. No other information provided at time of call. NO AE. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes: 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. 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).  Please provide a detailed description of the defect using the questions below: Is there a crack? NA If yes, describe the size, shape & depth of the crack: NA Provide the exact location of the crack on the syringe: NA  Is the syringe broken into 2 or more pieces? YES If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) 2 PIECES BROKEN OFF WHERE THE NEEDLE IS ATTACHED Provide the exact location of the breakage on the syringe? WHERE THE NEEDLE IS ATTACHED  Does the syringe have a broken component'? YES/NO/NA/UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) PER CALLER IT LOOKS LIKE A CLEAN BREAK If yes, describe in detail how it is broken. CLEAN BREAK NEAR WHERE THE NEEDLE IS ATTACHED Provide the exact location of the breakage on the syringe? WHERE THE NEEDLE IS ATTACHED Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES   Was there difficulty trying to attach the syringe needle to the syringe? NA  If yes, describe NA If yes, was it supplied by MERCK: NA If not supplied by MERCK, what type & brand, needle size & gauge was used?' NA  Under what situation was this defect noticed (select one): NOTCIED WHEN THEY OPENED THE PACKAGE AFTER RECIEVING IT While the syringe was still in the tray? HE REPORTED THAT THE SYRINGE WAS IN THE TRAY WHEEN THEY SHOWED IT TO HIM If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED Is there any broken glass or other separated component in the tray? (if yes specify) BROKEN INTO TWO PARTS  After removing the syringe from the tray? BEFORE THE SRYINGE THE SRYINGE WAS STILL IN THE TRAY  While trying to attach the needle to the syringe? NO While giving the injection? NO  Immediately after giving the injection? NO  Was the syringe tip cap attached properly prior to use? NO If no, describe issue: NA  Was the syringe tray intact and undamaged on receipt? NO If no, describe damage. PER CALLER ONE SYRINGE WAS DAMAGED UPON OPENING THE NEW SHIPMENT/PACKAGE   If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? PER CALLER THERE WAS NO DAMAGED NOTCIED TO THE PACKAGING If no, describe damage: na  Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) PRODUCT WAS NOT USED If yes, describe  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NA  If complaint sample is not/cannot be returned, please provide reason: YES  *If photos are available, ask the customer to send them  Retrieval Information: Obtain product (& tray if possible) 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:  12-DEC-2022 20:30 PM: Attachment added.  13-DEC-2022 Company Employee 1: Has been requested for complained product photographs and lot batch number of complained product. Due to the unavailability of the lot batch number, this record is processed as 'UNKNOWN VAXNEUVANCE' and manufacturing packaging sites are selected based on the supply chain map. Once The response is received, The record will be updated accordingly.  13-DEC-2022: Company Employee 2: Second person review completed.  13-DEC-2022 10:30 AM: Attachment added.  13-DEC-2022 10:30 AM: Attachment added.  13-DEC-2022 10:30 AM: Email case. PDF created as the additional information provided. 13-DEC-2022 10:30 AM: Email received in the Mailbox on 12-DEC-2022 at 7:06 PM with a photo for this case. PDF created as the original photo was embedded in the email. See attachments. No AE or additional PQC reported. No additional information provided.  13-DEC-2022 10:30 AM: Attachment added.  13-DEC-2022 10:30 AM: Waiting Retrieval site from Quality -- see attachment  13-DEC-2022 10:30 AM: Retrieval site.  13-DEC-2022 10:30 AM: Attachment added.  13-DEC-2022 Company Employee 1: Email communication The same is attached in reference section of this record.  13-DEC-2022 12:30 PM: Attachment added. 13-DEC-2022 12:30 PM: Email received in the Mailbox on 13-DEC-2022 at 2:49 AM from Quality with the following request: "Request you to provide the below information pertaining to the reported complaint. 1) Complained product photographs  2) Lot/ batch number" See attached. Forwarded to case owner for follow up.  13-DEC-2022 12:30 PM: Attachment added. 13-DEC-2022 12:30 PM: Labels Created. Shipped on 13-DEC-2022.   Complaint Description Summary Syringe was broken into two pieces where the needle is attached.