BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE B100L NG GREEN BULK AMG

    MDR report key: 8917573 · Received August 21, 2019

    Report

    Report Number
    3009081593-2019-00196
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    August 2, 2019
    Report Date
    September 23, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    FMF
    PMA / PMN Number
    K972878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: UNCONFIRMED, NO SAMPLE RECEIVED. THE CUSTOMER ISSUED A COMPLAINT FOR A NEEDLE GUARD DAMAGED/DEFECTIVE DETECTED BY END USER. NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRASAFE B100L NG GREEN BULK AMG THE NEEDLE GUARD "MAY HAVE BEEN A LITTLE CROOKED" THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE GREEN NEEDLE GUARD MAY HAVE BEEN A LITTLE CROOKED.¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8180960; MEDICAL DEVICE EXPIRATION DATE: 2022-06-30; DEVICE MANUFACTURE DATE: 2018-06-29. MEDICAL DEVICE LOT #: 8165754; MEDICAL DEVICE EXPIRATION DATE: 2022-05-31; DEVICE MANUFACTURE DATE: 2018-06-14. MEDICAL DEVICE LOT #: 8100792; MEDICAL DEVICE EXPIRATION DATE: 2022-03-31; DEVICE MANUFACTURE DATE: 2018-04-10. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRASAFE B100L NG GREEN BULK AMG THE NEEDLE GUARD "MAY HAVE BEEN A LITTLE CROOKED" THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE GREEN NEEDLE GUARD MAY HAVE BEEN A LITTLE CROOKED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712540 BD ULTRASAFE B100L NG GREEN BULK AMG PISTON SYRINGE FMF BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other