BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17786066 · Received September 20, 2023

    Report

    Report Number
    3014704491-2023-00573
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 14, 2023
    Report Date
    October 13, 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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3080068. 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 H10.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER THE PRN WAS LOOSE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: PREPARE THE PATIENT FOR PLACEMENT OF THE INDWELLING NEEDLE. THE INDWELLING NEEDLE IS INTACT, AND THE HEPARIN CAP FALLS OFF AFTER OPENING THE OUTER PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER THE PRN WAS LOOSE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: PREPARE THE PATIENT FOR PLACEMENT OF THE INDWELLING NEEDLE. THE INDWELLING NEEDLE IS INTACT, AND THE HEPARIN CAP FALLS OFF AFTER OPENING THE OUTER PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585821 BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080068 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown