BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SECONDARY SET C61

    MDR report key: 8503691 · Received April 11, 2019

    Report

    Report Number
    2243072-2019-00710
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    UDI-DI
    00382905153020
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR REVIEW WAS DONE AND NO ISSUES WERE REPORTED DURING PRODUCTION OF THIS LOTS. NO SAMPLE RECEIVED FOR THIS COMPLAINT, PHOTO WAS RECEIVED. CT SCAN WAS DONE ON LEAKING SAMPLE WHICH WAS SEGREGATED DURING PRODUCTION. AFTER THIS SCAN ADDITIONAL TESTS WERE DONE ON SPIKE COMPONENT AND THE CONCENTRICITY OF LOWER PART OF SPIKE COMPONENT CAUSED MOLDING DEFICIT ON ONE SIDE OF COMPONENT. CAPA#(B)(4) WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ SECONDARY SET C61 LEAKED WHEN STARTING INFUSION TO THE PATIENT. THIS OCCURRED ON 3 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM C61 THEY HAVE NOTICED THE LEAKAGE AT DEPARTMENT WHEN STARTING INFUSION TO PATIENT. THIS SAME HAVE OCCURRED 3 TIMES DURING SHORT TIME PERIOD. SAME KIND OF INCIDENT REPORTED FROM SAME DEPARTMENT 7.3.2019. NO PICTURE THIS TIME. THEY ARE NOT SURE IF ALL PRODUCTS ARE FROM SAME LOT AS THEY HAVE MANY BOXES OPEN.

    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 #: 1011753; MEDICAL DEVICE EXPIRATION DATE: 2022-09-30; DEVICE MANUFACTURE DATE: 2019-03-17; MEDICAL DEVICE LOT #: 1011580; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ SECONDARY SET C61 LEAKED WHEN STARTING INFUSION TO THE PATIENT. THIS OCCURRED ON 3 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM C61 THEY HAVE NOTICED THE LEAKAGE AT DEPARTMENT WHEN STARTING INFUSION TO PATIENT. THIS SAME HAVE OCCURRED 3 TIMES DURING SHORT TIME PERIOD. SAME KIND OF INCIDENT REPORTED FROM SAME DEPARTMENT (B)(6) 2019. NO PICTURE THIS TIME. THEY ARE NOT SURE IF ALL PRODUCTS ARE FROM SAME LOT AS THEY HAVE MANY BOXES OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300445 BD PHASEAL¿ SECONDARY SET C61 ADMINISTRATION SET LHI BECTON DICKINSON SEE H.10 00382905153020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other