BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PLUS PASSIVE NEEDLE GUARD

    MDR report key: 12542400 · Received September 28, 2021

    Report

    Report Number
    3009081593-2021-00036
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 3, 2021
    Report Date
    September 29, 2021
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 9/20/2021. H.6. INVESTIGATION: PHOTOS AND 1 SAMPLE WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. THE SAFETY DEVICE IS PARTIALLY ACTIVATED. ONE OF THE LATCH FINGERS IS BENT INWARD. 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 AND CHARACTERIZE THE CONDITION REPORTED BY THE CUSTOMER H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD LOCKING SAFETY TAB BENT INWARD AND PREVENTED RETRACTION. THIS OCCURRED ONCE IN LOT 0048552, AND AN UNSPECIFIED NUMBER OF TIMES IN LOT 0133618. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INFORMED BD OF A DEFECT ENCOUNTERED ON PASSIVE PLUS NSD: LOCKING TAB BENT INWARD, PREVENTING RETRACTION."

    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 #: 0048552, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-02-17; MEDICAL DEVICE LOT #: 0133618, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-05-12. 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 THE BD ULTRASAFE PLUS PASSIVE NEEDLE GUARD LOCKING SAFETY TAB BENT INWARD AND PREVENTED RETRACTION. THIS OCCURRED ONCE IN LOT 0048552, AND AN UNSPECIFIED NUMBER OF TIMES IN LOT 0133618. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INFORMED BD OF A DEFECT ENCOUNTERED ON PASSIVE PLUS NSD: LOCKING TAB BENT INWARD, PREVENTING RETRACTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438153 BD ULTRASAFE PLUS PASSIVE NEEDLE GUARD ANTISTICK SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1