BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE¿ MANUAL NEEDLE GUARD

    MDR report key: 7575024 · Received June 6, 2018

    Report

    Report Number
    3009081593-2018-00038
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 15, 2018
    Report Date
    June 22, 2018
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K972878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 6092157. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2016-04-01. MEDICAL DEVICE LOT #: 6031334. MEDICAL DEVICE EXPIRATION DATE: 2020-01-31. DEVICE MANUFACTURE DATE: 2016-01-31. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    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. THIS AVAILABLE INFORMATION IS NOT LINKED TO THE SAFETY DEVICE SO BD SHOULD NOT ABLE TO DEFINE POTENTIAL CAUSE LINKED TO SAFETY NEEDLE GUARD. 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 · 1

    IT WAS REPORTED THE GRAY NEEDLE CAP ON A BD ULTRASAFE¿ MANUAL NEEDLE GUARD WAS NOT ON THE UNIT AND THE MEDICATION LEAKED OUT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418397 BD ULTRASAFE¿ MANUAL NEEDLE GUARD SAFETY SYRINGE WITH NEEDLE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other