BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 10311746 · Received July 22, 2020

    Report

    Report Number
    3002682307-2020-00225
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 1, 2020
    Report Date
    August 7, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1901183. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, THE BLISTER PACKAGES WERE OBSERVED UNCUT. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM A FAILURE IN THE MACHINE CUTTING SYSTEM. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 30 BD¿ SYRINGES WITH NEEDLE HAD POOR PERFORATION ON THEIR PACKAGING UNITS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON JULY 1ST, 2020, TEACHER HUANG IN THE SECOND AREA NEEDED TO OPEN THE MIDDLE PACKAGE AND PREPARE TO USE A 20ML SYRINGE. IT WAS FOUND THAT THE SUTURES IN THE MIDDLE OF THE SYRINGE PACKAGE WERE NOT SEPARATED, MAKING IT IMPOSSIBLE TO TEAR THE PACKAGE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 30 BD¿ SYRINGES WITH NEEDLE HAD POOR PERFORATION ON THEIR PACKAGING UNITS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2020, TEACHER (B)(6) IN THE SECOND AREA NEEDED TO OPEN THE MIDDLE PACKAGE AND PREPARE TO USE A 20 ML SYRINGE. IT WAS FOUND THAT THE SUTURES IN THE MIDDLE OF THE SYRINGE PACKAGE WERE NOT SEPARATED, MAKING IT IMPOSSIBLE TO TEAR THE PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776045 BD SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other