BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET AN120 W/O BP

    MDR report key: 8488475 · Received April 5, 2019

    Report

    Report Number
    2243072-2019-00664
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 21, 2019
    Report Date
    April 25, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. CLAMPING TEST UNDER NORMAL USING CONDITION: SBDM CONDUCT CLAMPING TEST UNDER NORMAL USING CONDITION FOR THE COMPLAINT SAMPLE, THE CLAMP COULD HOLD MEDICINE AND THERE WAS NO DRUG INFUSION. CLAMPING TEST UNDER HIGH AIR PRESSURE: SBDM CONDUCT CLAMPING TEST UNDER AIR PRESSURE(0.51MPA) FOR THE COMPLAINT SAMPLES, THE CLAMP COULD HOLD AIR AND THERE WAS NO AIR BUBBLE LEAKAGE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 10 PCS EACH FROM LOTS (2901021, 2901072 AND 2902252) FROM HOUSE SAMPLE, NO ABNORMALITY WAS OBSERVED. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOTS 2901021, 2901072 AND 2902252, NO ABNORMALITY WAS OBSERVED. 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. SBDM INSPECTED THE COMPLAINT SAMPLE & HOUSE SAMPLES, THERE WAS NO MEDICINE INFUSION WHEN THE INFUSION SET WAS CLAMPING. SBDM THEN CONDUCTED CLAMPING TEST UNDER NORMAL USING CONDITION AND UNDER HIGH AIR PRESSURE THERE WAS NO DRUG INFUSION FOR BOTH TESTS. SBDM COULD NOT DETERMINE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ IV SET AN120 W/O BP LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALTHOUGH CLAMPING, DRUG WAS INFUSED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ IV SET AN120 W/O BP LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALTHOUGH CLAMPING, DRUG WAS INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282787 BD¿ IV SET AN120 W/O BP IV LHI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other