BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE

    MDR report key: 8752961 · Received July 2, 2019

    Report

    Report Number
    3002682307-2019-00386
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 13, 2019
    Report Date
    August 1, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD WAS NOT PROVIDED WITH PHOTOS OR AFFECTED SAMPLES FOR CATALOG 303129 LOT 190409 TO INVESTIGATE FOR THIS RECORD. 85 REFERENCE SAMPLES WERE EXAMINED AND THEY DID NOT REVEAL ANY DAMAGE IN HUB. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE NEEDLE BROKE AT ITS BASE WHEN ATTACHED TO VIAL WITH A BD BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE HDJ CHEMOTHERAPY DEPARTMENT OF OUR HOSPITAL ENCOUNTERED A PROBLEM WITH A PUMP NEEDLE ON (B)(6) 2019. PROBLEM DESCRIPTION: "WHEN PREPARING INJECTABLE PRODUCTS, THE 18G 1.2X40MM NEEDLES BROKE AT THEIR BASE. THIS HAPPENED TO 2 NURSES WITH 3 DIFFERENT PUMPERS. WHEN THE NEEDLE WAS INTRODUCED INTO THE VIAL, THE NEEDLE BROKE CLEANLY." PRODUCT REFERENCE : 303129 LOT: 190409 EQUIPMENT KEPT: YES, AVAILABLE FOR ANALYSIS ADDITIONAL INFORMATION FROM THE CUSTOMER: SERIOUS INJURY? NO ERRONEOUS RESULTS? NO COURSE OF TREATMENT CHANGED EXPOSURE TO BLOOD/BODILY FLUID? NO MEDICAL INTERVENTION? NO.

    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 DURING USE THE NEEDLE BROKE AT ITS BASE WHEN ATTACHED TO VIAL WITH A BD BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE HDJ CHEMOTHERAPY DEPARTMENT OF OUR HOSPITAL ENCOUNTERED A PROBLEM WITH A PUMP NEEDLE ON (B)(6) 2019. PROBLEM DESCRIPTION: "WHEN PREPARING INJECTABLE PRODUCTS, THE 18G 1.2X40MM NEEDLES BROKE AT THEIR BASE. THIS HAPPENED TO 2 NURSES WITH 3 DIFFERENT PUMPERS. WHEN THE NEEDLE WAS INTRODUCED INTO THE VIAL, THE NEEDLE BROKE CLEANLY." PRODUCT REFERENCE: (B)(4), LOT: 190409, EQUIPMENT KEPT: YES, AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION FROM THE CUSTOMER: SERIOUS INJURY? NO, ERRONEOUS RESULTS? NO, COURSE OF TREATMENT CHANGED EXPOSURE TO BLOOD/BODILY FLUID? NO, MEDICAL INTERVENTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548019 BD BLUNT FILL NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 190409

    Patients

    Seq Age Sex Outcome Treatment
    1 Other