BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRN ADAPTER

    MDR report key: 17167968 · Received June 20, 2023

    Report

    Report Number
    3014704491-2023-00274
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 25, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K933467
    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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2222245. 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

    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 · 0

    IT WAS REPORTED THAT DURING USE WITH BD¿ PRN ADAPTER THE PRN HAD LOOSE CONNECTION AND LEAKED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: 2023.5.24 A NEW HEPARIN CAP WAS INSERTED WITH AN INDWELLING NEEDLE AFTER LAPAROSCOPIC OPERATION IN WARD 29. THE CAP MOUTH OF THE HEPARIN CAP CONNECTED TO THE SCALP NEEDLE WAS LEAKING AND COULD NOT BE USED NORMALLY. A NEW HEPARIN CAP WAS REPLACED AND USED NORMALLY WITHOUT CAUSING ADVERSE HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD¿ PRN ADAPTER THE PRN HAD LOOSE CONNECTION AND LEAKED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: (B)(6) 2023. A NEW HEPARIN CAP WAS INSERTED WITH AN INDWELLING NEEDLE AFTER LAPAROSCOPIC OPERATION IN WARD 29. THE CAP MOUTH OF THE HEPARIN CAP CONNECTED TO THE SCALP NEEDLE WAS LEAKING AND COULD NOT BE USED NORMALLY. A NEW HEPARIN CAP WAS REPLACED AND USED NORMALLY WITHOUT CAUSING ADVERSE HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692398 BD¿ PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2222245

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown