BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 14949311 · Received July 7, 2022

    Report

    Report Number
    8041187-2022-00346
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    May 30, 2022
    Report Date
    July 14, 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 1053338. 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 THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM LEAKED FROM THE TUBE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PATIENT WAS HOSPITALIZED FOR DIABETES AT 10:00 ON (B)(6) 2022, AND WAS TREATED WITH INDWELLING VENOUS INDWELLING NEEDLE AND INFUSION ACCORDING TO THE DOCTOR'S ADVICE. WHEN THE INDWELLING NEEDLE WAS CONNECTED AGAIN AT 14:00, FLUID LEAKAGE WAS FOUND IN THE SOFT CONNECTING TUBE. THE INDWELLING NEEDLE WAS REMOVED AND A NEW INDWELLING NEEDLE WAS IMPLANTED AGAIN." "CATHETER TUBING LEAKAGE DUE TO IMPROPER OPERATION OF NURSE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM LEAKED FROM THE TUBE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PATIENT WAS HOSPITALIZED FOR DIABETES AT 10:00 ON MAY 31, 2022, AND WAS TREATED WITH INDWELLING VENOUS INDWELLING NEEDLE AND INFUSION ACCORDING TO THE DOCTOR'S ADVICE. WHEN THE INDWELLING NEEDLE WAS CONNECTED AGAIN AT 14:00, FLUID LEAKAGE WAS FOUND IN THE SOFT CONNECTING TUBE. THE INDWELLING NEEDLE WAS REMOVED AND A NEW INDWELLING NEEDLE WAS IMPLANTED AGAIN." "CATHETER TUBING LEAKAGE DUE TO IMPROPER OPERATION OF NURSE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2672596 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1053338

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown