BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 16390714 · Received February 16, 2023

    Report

    Report Number
    3003152976-2023-00028
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    January 25, 2023
    Report Date
    January 26, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, AND THE STOPPER WAS VERIFIED TO BE INCORRECTLY ASSEMBLED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2110708, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. A CAMERA SYSTEM IS USED IN THE ASSEMBLY MACHINE TO DETECT MISSING OR IMPROPERLY ASSEMBLED STOPPERS. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY ALONG WITH THE DETECTION SYSTEM NOT PROPERLY IDENTIFYING AND DISCARDING THE IMPACTED SAMPLE. BASED ON THE PREVENTIVE MEASURES IN PLACE AND THE CURRENT INSPECTION PROCESS, THIS IS BELIEVED TO BE AN ISOLATED ISSUE WITH AN UNLIKELY RECURRENCE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE STOPPER SEPARATED FROM PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE OBSERVE THIS DAY AT THE OPENING OF THE BLISTER, THAT IS TO SAY BEFORE USE, THE JOINT WHICH IS UNSTUCK ON THE REFERENCE (B)(4) SYRINGE 30ML LL OF THE BATCH 2110708:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354453 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown