BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN LUER SLIP ADAPTER

    MDR report key: 10932953 · Received December 2, 2020

    Report

    Report Number
    3006948883-2020-00872
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 6, 2020
    Report Date
    February 9, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    PMA / PMN Number
    K933467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0052703. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS BATCH OF PRN. 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, DUE TO CURRENT CUSTOMS LAWS IN CHINA MEDICAL DEVICES CANNOT BE SHIPPED INTO THE COUNTRY. PHOTOGRAPHS OF THE SUBMITTED DEVICE WERE SUBMITTED TO OUR TEAM IN SUZHOU BUT FUNCTIONAL TESTING WAS NOT POSSIBLE. IN LIEU OF THE AFFECTED UNIT OUR ENGINEERSS SUBJECTED THE AVAILABLE RETENTION SAMPLES TO FUNCTIONAL TESTING. BASED ON THE RESULTS OF THEIR TESTING. THEY FOUND THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS RELATED TO THE INSERTION OF THE PRN INTO THE CORRESPONDING DEVICE. IF THE PRN IS NOT INSERTED WITH SUFFICIENT FORCE OR IF THE CORRESPONDING DEVICE IS INCOMPATIBLE WITH THE BD PRN LEAKAGE MAY OCCUR. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OR MORE INFORMATION REGARDING THE DEVICE BEING USED IN CONJUNCTION WITH THE BD PRN, OUR QUALITY ENGINEERS WERE UNABLE TO CONFIRM THE ROOT CAUSE FOR THIS COMPLAINT. CAPA#1474444 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD PRN LUER SLIP ADAPTER LEAKAGE AT LUER CONNECTION OCCURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT FROM AN ANIMAL CLINIC ABOUT LEAKAGE. ACCORDING TO THE CUSTOMER'S REPORT, THE ADAPTER COULD NOT FIT PROPERLY AND LEAKAGE THEN OCCURRED.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH BD PRN LUER SLIP ADAPTER LEAKAGE AT LUER CONNECTION OCCURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH, "THIS IS A REPORT FROM AN ANIMAL CLINIC ABOUT LEAKAGE. ACCORDING TO THE CUSTOMER'S REPORT, THE ADAPTER COULD NOT FIT PROPERLY AND LEAKAGE THEN OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402020 BD PRN LUER SLIP ADAPTER INTRAVASCULAR CATHETER FPA BD (SUZHOU) 0052703

    Patients

    Seq Age Sex Outcome Treatment
    1