BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION SET (C61)

    MDR report key: 8395709 · Received March 6, 2019

    Report

    Report Number
    2243072-2019-00420
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 13, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DHR REVIEW WAS DONE AND NO ISSUES WERE REPORTED DURING PRODUCTION OF THIS LOT. NO SAMPLE RECEIVED FOR THIS COMPLAINT. CT SCAN WAS DONE ON LEAKING SAMPLE WHICH WAS SEGREGATED DURING PRODUCTION. AFTER THIS SCAN ADDITIONAL TESTS WERE DONE ON SPIKE COMPONENT AND CONCENTRICITY OF LOWER PART OF SPIKE COMPONENT CAUSED MOLDING DEFICIT ON ONE SIDE OF COMPONENT. CAPA#891423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SETS OF BD PHASEAL¿ INFUSION SET (C61) ARE LEAKING. WHEN APPLYING THE CYTOSTATICS DRUG IT LEAKED ON THE BACK OF THE INTEGRATED CONNECTOR.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1010228; MEDICAL DEVICE EXPIRATION DATE: 2022-03-31; DEVICE MANUFACTURE DATE: 2018-11-22; MEDICAL DEVICE LOT #: 1011186; MEDICAL DEVICE EXPIRATION DATE: 2022-04-30; DEVICE MANUFACTURE DATE: 2019-01-31." (B)(6). 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 2 SETS OF BD PHASEAL¿ INFUSION SET (C61) ARE LEAKING. WHEN APPLYING THE CYTOSTATICS DRUG IT LEAKED ON THE BACK OF THE INTEGRATED CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186651 BD PHASEAL¿ INFUSION SET (C61) ADMINISTRATION SET LHI BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other