BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC

    MDR report key: 19198339 · Received April 26, 2024

    Report

    Report Number
    3002601200-2024-00155
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 20, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903837564
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3234106. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2024, THE PATIENT WAS UNDERGOING PREOPERATIVE REHYDRATION THERAPY FOR ENDOMETRIAL CANCER AS PRESCRIBED BY THE PHYSICIAN, AND A CLOSED ANTI-NEEDLE-STICK INJURY TYPE IV INDWELLING NEEDLE WAS GIVEN AT 10:12 TO OPEN VENOUS ACCESS, AND THERE WAS A LEAKAGE AT THE END OF THE INDWELLING NEEDLE AT 10:14, WHICH WAS IMMEDIATELY REASSURED TO THE PATIENT AND REPLACED WITH A NEW ONE OF THE SAME TYPE FOR USE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982470 BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3234106 00382903837564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown