BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 10336369 · Received July 28, 2020

    Report

    Report Number
    3006948883-2020-00314
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    December 8, 2019
    Report Date
    August 20, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233049. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ PRN ADAPTER HEPARIN CAP LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON (B)(6) 2019, THE NURSE NORMALLY USED THE DISPOSABLE HEPARIN CAP. DURING THE TRANSFUSION, THE PATIENT FOUND THE LEAKAGE OF HEPARIN CAP, AND INFORMED THE NURSE TO REPLACE ANOTHER HEPARIN CAP, WHICH DID NO HARM TO THE PATIENT".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ PRN ADAPTER HEPARIN CAP LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2019, THE NURSE NORMALLY USED THE DISPOSABLE HEPARIN CAP. DURING THE TRANSFUSION, THE PATIENT FOUND THE LEAKAGE OF HEPARIN CAP, AND INFORMED THE NURSE TO REPLACE ANOTHER HEPARIN CAP, WHICH DID NO HARM TO THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799929 BD PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233049

    Patients

    Seq Age Sex Outcome Treatment
    1 Other