BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER

    MDR report key: 16592035 · Received March 22, 2023

    Report

    Report Number
    3014704491-2023-00068
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 8, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2200359. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER THE PRN WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER PUNCTURE, FLUID LEAKED FROM THE SIDE OF THE HEPARIN CAP THAT CAME WITH THE INDWELLING NEEDLE. THE HEPARIN CAP WAS OCCASIONALLY FOUND TO BE DAMAGED AND REPLACED IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843845 BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2200359 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown