BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGE

    MDR report key: 9118268 · Received September 25, 2019

    Report

    Report Number
    3009081593-2019-00217
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    August 9, 2019
    Report Date
    October 21, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K122558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 268 SAMPLES WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEMS (BDM-PS) FOR ANALYSIS. WHICH CONSISTED OF ALL SAMPLES IDENTIFIED AS BAD SAMPLES BY CUSTOMER. THE SAMPLES PASSED ALL RELEASE CRITERIA. IT WAS NOTED BD SAW ON 121 BAD SAMPLES WHAT WERE POSSIBLE TO ASSEMBLE WITH SYRINGE WITHOUT ANY DIFFICULTIES, ANOTHER 34 BAD SAMPLES WITH OVERLAPPED SPRING WHAT WEREN¿T POSSIBLE TO ASSEMBLE WITH SYRINGE, 98 PARTIAL ACTIVATED DEVICES, 3 DEVICES WITH BROKEN OR DAMAGED TRIGGER FINGER COVER, 8 PREACTIVATED DEVICES. THERE ARE 7 DAMAGED SAMPLES WHICH CAME FROM THE ASSEMBLY LINE OF DIRECT CUSTOMER. THERE IS NO CRITERIA IN THE SPECIFICATION FOR THIS CRITERIA. 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 ABLE TO CONFIRM THE DETECTION OF THE SYMPTOM PERCEIVED BY CUSTOMER. BD WORKING ON REFURBISH THE COILER'S.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEFECTS WERE FOUND BEFORE USE WITH BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DEFECTED ULTRASAFE DEVICES LEADING TO PERFORMANCE ISSUES DURING THE DEVICE ASSEMBLY ON SYRINGE PACKAGING LINE 4 AND 6. "

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9086791, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-03-27. MEDICAL DEVICE LOT #: 9122506, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-05-02. 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 DEFECTS WERE FOUND BEFORE USE WITH BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DEFECTED ULTRASAFE DEVICES LEADING TO PERFORMANCE ISSUES DURING THE DEVICE ASSEMBLY ON SYRINGE PACKAGING LINE 4 AND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915474 BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGE SYRINGE, ANTISTICK MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other