Sex: U
Vaccine: PPV
Symptoms: Device breakage, Product blister packaging issue, Product packaging quantity issue, Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;N/A;Broken Syringe; damaged barcode label; Complaint Description Detail  Email received on 3-AUG-2022 at 2:41 pm with a request to create a PQC case for PNEUMOVAX 23 if an original case cannot be located for a returned box containing PNEUMOVAX 23 carton from lot T027110.   Quality reports the following: "Box received today had a label over it saying" Relabel  Relabel Reason: DAMAGED BARCODE LABEL) with tracking # 889033869749802 And I can only make out on a label underneath the relabeled one company address. Pls. see if you can determine who the sender for this shipment on their website.  Box contains a Pneumovax 23 carton from lot T027110 containing two blister packs (one sealed blister pack with five syringes and one of the syringes has a broken finger flange) and the other a previously opened blister pack with two syringes. All contents are from the same lot T027110."   PQC first identified date reflects the date the products were received as an original case cannot be located. Unable to follow up as customer is unknown. Will mark product return date as "today" since product was received by quality today. No AE, no additional information. Attachment added to Service Cloud. Sample Tracking Number:  User's Experience: Unknown Insertion Difficulty:  Insertion Difficulty Details:  Doubt About Presence:  Doubt Details:  Migration:  Migration Details:   Removal Problem:   Removal Problem Details:  03-AUG-2022 16:30 PM :**Unable to answer any questions as quality received product, unable to locate original case and customer is unknown at this time**  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? UNKNOWN                 - If yes, describe the size, shape & depth of the crack: UNKNOWN                 - Provide the exact location of the crack on the syringe: UNKNOWN         * Is the syringe broken into 2 or more pieces?UNKNOWN                 - If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.)                 - Provide the exact location of the breakage on the syringe?   UNKNOWN          * Does the syringe have a broken component? UNKNOWN (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange)                 - If yes, describe in detail how it is broken. UNKNOWN                 - Provide the exact location of the breakage on the syringe? UNKNOWN                 - Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? UNKNOWN (if yes describe)          * Was there difficulty trying to attach the syringe needle to the syringe? UNKNOWN                    - If yes, describe                    - If yes, was it supplied by MERCK: UNKNOWN                    - If not supplied by MERCK, what type & brand, needle size & gauge was used? UNKNOWN  Under what situation was this defect noticed: (select one)         * While the syringe was still in the tray? UNKNOWN                 - If yes, is there product (liquid or dried residue) in the tray? UNKNOWN                 - Is there any broken glass or other separated component in the tray? (if yes specify)          * After removing the syringe from the tray? UNKNOWN          * While trying to attach the needle to the syringe? UNKNOWN          * While giving the injection? UNKNOWN          * Immediately after giving the injection? UNKNOWN  Was the syringe tip cap attached properly prior to use? UNKNOWN          * If no, describe issue:  Was the syringe tray intact and undamaged on receipt? UNKNOWN         * 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. UNKNOWN         * If no, describe damage  Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNKNOWN          * If yes, describe  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? UNKNOWN  If complaint sample is not/cannot be returned, please provide reason: NA  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.  04-AUG- 2022; Second person reviewed by Reviewer 1.  Complaint Description Summary Received  containing PNEUMOVAX 23 10 count carton with seven syringes (one of them with a broken finger flange).