BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS BL 22GA X 1.00IN PRN

    MDR report key: 14340455 · Received May 9, 2022

    Report

    Report Number
    8041187-2022-00243
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 7, 2022
    Report Date
    May 18, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1231588. 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 BD PEGASUS BL 22GA X 1.00IN PRN HAD LEAKAGE AT THE CATHETER JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE PERFORMED SUPERFICIAL VEIN INDWELLING FOR THE PATIENT, AND CHECKED THE INTEGRITY OF THE EXTERNAL PACKAGE OF THE INDWELLING NEEDLE. WITHIN THE VALIDITY PERIOD, THE INDWELLING NEEDLE WAS REMOVED FOR EXHAUSTING BEFORE PUNCTURE, AND WATER SEEPAGE WAS FOUND AT THE CONNECTION BETWEEN THE NEEDLE HANDLE AND THE CATHETER TUBE."

    Description of Event or Problem · 0

    IT WAS REPORTED BD PEGASUS BL 22GA X 1.00IN PRN HAD LEAKAGE AT THE CATHETER JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...THE NURSE PERFORMED SUPERFICIAL VEIN INDWELLING FOR THE PATIENT, AND CHECKED THE INTEGRITY OF THE EXTERNAL PACKAGE OF THE INDWELLING NEEDLE. WITHIN THE VALIDITY PERIOD, THE INDWELLING NEEDLE WAS REMOVED FOR EXHAUSTING BEFORE PUNCTURE, AND WATER SEEPAGE WAS FOUND AT THE CONNECTION BETWEEN THE NEEDLE HANDLE AND THE CATHETER TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535241 BD PEGASUS BL 22GA X 1.00IN PRN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1231588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown