BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION SET (C61)

    MDR report key: 8608949 · Received May 14, 2019

    Report

    Report Number
    2243072-2019-00920
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    April 29, 2019
    Report Date
    July 9, 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. SAMPLE WAS RECEIVED OPENED FROM THE ORIGINAL PACKAGING AND STILL ATTACHED TO THE NACL BOTTLE. TWO UNOPENED SAMPLES RECEIVED AS WELL. SAMPLE RECEIVED WAS TESTED FOR LEAKAGE, SAMPLE FAILED THE TEST ON SPIKE-TUBE JOINT. TWO UNOPENED SAMPLES WERE TESTED AS WELL AND THEY PASSED. CT SCAN WAS DONE ON LEAKING SAMPLE WHICH WAS SEGREGATED DURING PRODUCTION. AFTER THIS SCAN ADDITIONAL TESTS WERE DONE ON SPIKE COMPONENT. CONCENTRICITY OF LOWER PART OF SPIKE COMPONENT CAUSED MOLDING DEFICIT ON ONE SIDE OF COMPONENT. CAPA#(B)(4) WAS INITIATED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE WITH A BD PHASEAL¿ INFUSION SET (C61). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: UNFORTUNATELY I HAVE TO REPORT YOU, THAT WE NOTICED LEAKAGE AGAIN . BECAUSE WE DID NOT FILL THE BAG YET. THE SOLUTION CAME OUT (AT THE BACK SIDE OF THE INTEGRATED CONNECTOR).

    Additional Manufacturer Narrative · 1

    (B)(4). "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1011580, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2019-03-30. MEDICAL DEVICE LOT #: 1011753, MEDICAL DEVICE EXPIRATION DATE: 2022-09-30, DEVICE MANUFACTURE DATE: 2019-03-17. " (B)(6). DEVICE EVALUATED BY MFR: 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 THERE WAS LEAKAGE WITH A BD PHASEAL¿ INFUSION SET (C61). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED: UNFORTUNATELY I HAVE TO REPORT YOU, THAT WE NOTICED LEAKAGE AGAIN . BECAUSE WE DID NOT FILL THE BAG YET. THE SOLUTION CAME OUT (AT THE BACK SIDE OF THE INTEGRATED CONNECTOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403724 BD PHASEAL¿ INFUSION SET (C61) ADMINISTRATION SET LHI BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other