BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRN ADAPTER

    MDR report key: 9418544 · Received December 5, 2019

    Report

    Report Number
    3006948883-2019-01033
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 14, 2019
    Report Date
    January 13, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233030. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION LEAKED PAST THE BD¿ PRN ADAPTER HEPARIN CAP DURING USE ON A PATIENT BEING TREATED FOR "ACUTE LYMPHOCYTIC LEUKEMIA". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE PATIENT WAS ADMITTED TO OUR HOSPITAL FOR TREATMENT DUE TO ACUTE LYMPHOCYTIC LEUKEMIA, AND THE DISPOSABLE HEPARIN CAP AND DISPOSABLE INTRAVENOUS CATHETER WERE USED TOGETHER FOR PUNCTURE INFUSION. DURING THE USE, THE HEPARIN CAP LEAKED, WHICH WAS UNABLE TO BE USED, WASTED MEDICAL RESOURCES, PROLONGED THE TREATMENT TIME, AND THE TREATMENT CONTINUED AFTER THE NEW HEPARIN CAP WAS IMMEDIATELY REPLACED."

    Additional Manufacturer Narrative · 1

    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 MEDICATION LEAKED PAST THE BD¿ PRN ADAPTER HEPARIN CAP DURING USE ON A PATIENT BEING TREATED FOR "ACUTE LYMPHOCYTIC LEUKEMIA". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE PATIENT WAS ADMITTED TO OUR HOSPITAL FOR TREATMENT DUE TO ACUTE LYMPHOCYTIC LEUKEMIA, AND THE DISPOSABLE HEPARIN CAP AND DISPOSABLE INTRAVENOUS CATHETER WERE USED TOGETHER FOR PUNCTURE INFUSION. DURING THE USE, THE HEPARIN CAP LEAKED, WHICH WAS UNABLE TO BE USED, WASTED MEDICAL RESOURCES, PROLONGED THE TREATMENT TIME, AND THE TREATMENT CONTINUED AFTER THE NEW HEPARIN CAP WAS IMMEDIATELY REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215471 BD¿ PRN ADAPTER PRN ADAPTER FOZ BD (SUZHOU) 8233030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other