Sex: U
Vaccine: PNC15
Symptoms: Needle issue, Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;Broken;Syringe Hub Defect; Complaint Description Detail Called to report PQC. Customer placed on phone to obtain information. Caller reported he found a broken PFS during his inventory. No AE reported. Customer will send pictures and Customer will hold product for return.  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 ii 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? NO 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.) TIP/CAP BROKEN OFF Provide the exact location of the breakage on the syringe? LEUR-LOCK  Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) If yes, describe in detail how it is broken. TIP IS BROKEN OFF Provide the exact location of the breakage on the syringe? LEUR-LOCK Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES (if yes describe) LEURLOCK IS BROKEN OFF 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) While the syringe was still in the tray? YES If yes, is there product (liquid or dried residue) in the tray? YES Is there any broken glass or other separated component in the tray? (if yes specify) YES -THE LEURLOCK IS IN 2 PIECES  After removing the syringe from the tray? NO  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? YES If no, describe issue:  Was the syringe tray intact and undamaged on receipt? YES If no, describe damage.  If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? see below. YES If no, describe damage  Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO If yes, describe  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO  If complaint sample is not/cannot be returned, please provide reason:  If photos are available, ask the customer to send them to MSD  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:  07-OCT-2022 12:30: Attachment added to Service Cloud. 07-OCT-2022; Photos are attached 07-OCT-2022 13:30: Attachment added to Service Cloud. 07-OCT-2022 13:30: Attachment added to Service Cloud.  07-OCT-2022 13:30: Email received in the Mailbox on 07OCT2022 at 11:48am with pictures for this case. Pictures were embedded in the email so they were saved and uploaded separately. See attachments.  07-OCT-2022 14:30: This Case's Caller who was Merck Field Employee was Following-Up with this Case. At current call time, Caller, on this Case's Office Manager's Behalf, provided additional event detail information for this Case; as confirmed by Caller at current call time, this Case's Office Manager had confirmed how this Case's Office Manager's Facility was not requesting PQC Replacement in response to this Case having opted instead to follow-up with this Case's Office Manager's Facility's Wholesaler/VAXCARE, as confirmed by Caller at current call time, this Case's Affected Product was still available for Return prior to and at current call time, and as confirmed by Caller at current call time, this Case's Office Manager gave permission to be contacted in future regarding this Case's event. No additional PQC details provided. No additional PQC reported. No AE reported. No further information provided.  07-OCT-2022 14:30: Email received on 07-OCT-2022 at 12:57 from the customer with: "I was just informed by Vaxcare we are responsible to ship the damaged vaccines back to vaxcare for inventory and financial responsibilities etc. So our office is being liable IF we ship back to Merck directly so I assume the shipment from Merck should be canceled for both replacement and the return box etc" See attachment. Case owner notified.  07-OCT-2022 14:30: A new case was opened to add additional attachments to this case. The case number 02263736. The attachment for note N-805660 can be found within this new case.  07-OCT-2022 15:30: Outbound call the customer to confirm product will not be returned as stated in email. Message left of voicemail. Case reopened to uncheck the obtain box for the product. No new information received. No AE/or additional PQC reported.  07-OCT-2022 15:30: Clarification for Quality: Product will not be returned to MERCK by customer as Vaxserve has instructed customer to return the product to them.  07-OCT-2022: Second person review performed by A.