BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 15CM LUER-LOK POWER INJECTABLE

    MDR report key: 8336623 · Received February 13, 2019

    Report

    Report Number
    9610847-2019-00155
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 23, 2019
    Report Date
    March 8, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K142527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FAILURE MODE NOT CONFIRMED. SAMPLE PART PASSED THE LEAKAGE TESTS (AIR PRESSURE DECAY AND WATER TESTS) AND NO TUBING SEPARATION WAS OBSERVED. COMPLAINT HISTORY CHECK FOR LOT 8242512 WAS VERIFIED AND NO DISCREPANCIES WERE FOUND ABOUT THE ABOVE DESCRIBED PROBLEM. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 8242512. NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 8242512 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. LOT NO #: 8242512 CATALOGUE #: NS385154 QUANTITY PRODUCED: (B)(4). EXTENSION SET LOTS (P/N (B)(4)) USED ARE AO17L03 AND AO18D01 FOR LOT 8242512. NO QN¿S WERE FOUND FOR LOTS AO17L03 AND AO18D01 (USED FOR NS385154) IN SAP AND INCOMING INSPECTION RECORDS. DURING THE MANUFACTURE OF THIS PRODUCT, 100% VISUAL INSPECTION IS PERFORMED FOR VISUAL DEFECTS AND LEAKAGE TEST IS PERFORMED PER QCPA-14SP. DURING THE 100% INSPECTION, NO VISUAL DEFECTS WERE DETECTED BY OUR OPERATORS. NO LEAKAGE FAILURES DETECTED BY INSPECTION TECHNICIANS. THE MANUFACTURING PROCESS WAS REVIEWED AND NO POTENTIAL FAILURES WERE IDENTIFIED SINCE ONLY THE Q-SYTE CONNECTORS ARE ASSEMBLED TO THE BD EXTENSION SETS AND THEN PACKAGED IN THE NOGALES MANUFACTURING PROCESS. SAMPLE PART PASSED THE LEAKAGE TESTS (AIR PRESSURE DECAY AND WATER TESTS) AND NO TUBING SEPARATION WAS OBSERVED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE SINCE THE SAMPLE PART PASSED THE LEAKAGE TESTS (AIR PRESSURE DECAY AND WATER TESTS) AND NO TUBING SEPARATION WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A EXT SET 15CM LUER-LOK POWER INJECTABLE HAD LEAKED FROM THE HUB AND SEPARATED WHERE IT ATTACHES TO THE INSYTE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A EXT SET 15CM LUER-LOK POWER INJECTABLE HAD LEAKED FROM THE HUB AND SEPARATED WHERE IT ATTACHES TO THE INSYTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131223 EXT SET 15CM LUER-LOK POWER INJECTABLE CATHETER FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8242512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other