BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN

    MDR report key: 12316758 · Received August 12, 2021

    Report

    Report Number
    9610847-2021-00368
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 15, 2021
    Report Date
    August 23, 2021
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1053923. D.4. MEDICAL DEVICE EXPIRATION DATE: 2/28/2025. H.4. DEVICE MANUFACTURE DATE: 3/9/2021. D.4. MEDICAL DEVICE LOT #: 1053927. D.4. MEDICAL DEVICE EXPIRATION DATE: 2/28/2025. H.4. DEVICE MANUFACTURE DATE: 3/16/2021. D.4. MEDICAL DEVICE LOT #: 1021363. D.4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2025. H.4. DEVICE MANUFACTURE DATE: 2/25/2021. H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED TEN BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN HAD DAMAGED CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BELOW IS A BREAKDOWN OF THE DEFECTIVE DEVICES THAT HAVE BEEN REPORTED TO ME SO FAR."

    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 #: 1053923 MEDICAL DEVICE EXPIRATION DATE: 02/28/2025 DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1053927 MEDICAL DEVICE EXPIRATION DATE: 02/28/2025 DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1021363 MEDICAL DEVICE EXPIRATION DATE: 01/31/2025 DEVICE MANUFACTURE DATE: (B)(6) 2021. 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 TEN BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN HAD DAMAGED CATHETERS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BELOW IS A BREAKDOWN OF THE DEFECTIVE DEVICES THAT HAVE BEEN REPORTED TO ME SO FAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212663 BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN INTRAVASCULAR CATHETER FOZ 383313 SEE H.10 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1