BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2

    MDR report key: 8475934 · Received April 2, 2019

    Report

    Report Number
    3002682307-2019-00226
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 22, 2019
    Report Date
    May 31, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLE FOR CATALOG 301942, LOT 1802143, TO INVESTIGATE FOR THIS RECORD. VISUAL INSPECTION OF THE SAMPLE REVEALED A PIECE OF THE PIN RACK IN THE HUB COMING FROM THE ASSEMBLY NEEDLE MACHINE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. IN ORDER TO MOVE THE PIECES THROUGH THE ASSEMBLING PROCESS, THE NEEDLES ARE LOCATED IN SOME PLASTIC RACKS MADE OF GREEN POLYCARBONATE. BASED ON THE REPORTED ISSUE, OUR OPINION IS THAT ONE OF THESE "RACK PINS" MAY BREAK BECAUSE OF ANY BLOCKAGE IN THE MANUFACTURING PROCESS REMAINING ATTACHED TO THE NEEDLE. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWENTY BD¿ SYRINGE S2 HAD FOREIGN MATTER ON THE NEEDLE BEFORE USE. FOREIGN COMPLAINTS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ¿ AFTER OPENING THE UNIT PACKAGE, A PLASTIC FOREIGN MATTER IN NEEDLE HUB.20 AFFECTED SAMPLES IN ONE SHELF CARTON WAS FOUND ¿.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWENTY BD¿ SYRINGE S2 HAD FOREIGN MATTER ON THE NEEDLE BEFORE USE. FOREIGN COMPLAINTS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ¿AFTER OPENING THE UNIT PACKAGE,A PLASTIC FOREIGN MATTER IN NEEDLE HUB.20 AFFECTED SAMPLES IN ONE SHELF CARTON WAS FOUND".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269713 BD SYRINGE S2 SYRINGE FMF BECTON DICKINSON, S.A. 1802143

    Patients

    Seq Age Sex Outcome Treatment
    1 Other