BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET/20DROP/WR3CQ/STD/100CM

    MDR report key: 8279050 · Received January 25, 2019

    Report

    Report Number
    2243072-2019-00109
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    January 9, 2019
    Report Date
    February 12, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE ACTUAL PRODUCT WAS RETURNED AND THE SECTION OF THE CUT SECTION HAD A DISTORTED SHAPE. IN ADDITION, THIS PRODUCT WAS CONDUCTING THE ALL-IN-ONE VISUAL INSPECTION JUST BEFORE PUTTING IT INTO INDIVIDUAL PACKAGING. IN ADDITION, THIS PRODUCT PASSED THE TENSILE STRENGTH TEST (JIS TENSILE STRENGTH STANDARD OF TARGET JIS TENSILE STRENGTH STANDARD: NO ABNORMALITY IS OBSERVED WHEN LOAD OF 15 N IS APPLIED FOR 15 SECONDS, SAMPLING INSPECTION N = 8 PIECES) IN SHIPMENT TEST OF ALL PAST PRODUCTION LOT WAS DOING. AS THE CROSS SECTION IS DISTORTED, IT WAS ESTIMATED THAT THE TUBE WAS CUT DUE TO EXCESSIVE LOAD APPLIED TO THE TUBE DURING USE. A DHR COULD NOT BE COMPLETED AS THE BATCH# IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE IV SET/20DROP/WR3CQ/STD/100CM THERE WAS AN ISSUE WITH TUBING CUT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ATOM. THIS SITE IS NOT A BD 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 IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE IV SET/20DROP/WR3CQ/STD/100CM THERE WAS AN ISSUE WITH TUBING CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69728 IV SET/20DROP/WR3CQ/STD/100CM IV ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other