BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 16091172 · Received January 3, 2023

    Report

    Report Number
    8041187-2022-00782
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 8, 2022
    Report Date
    February 3, 2023
    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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2110383. 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.

    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 THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2022, THE NURSE IN THE NEUROLOGY WARD INJECTED AN INDWELLING NEEDLE FOR THE PATIENT, AND AFTER THE INDWELLING NEEDLE PUNCTURED INTO THE PATIENT'S SKIN, THE NURSE FOUND THAT THERE WAS BLOOD OOZING FROM THE TAIL OF THE PINTLE OF THE INDWELLING NEEDLE. THE NURSE WITHDRAWS AND SEALS UP THE BLEEDING INDWELLING NEEDLE, AND THEN PUNCTURES A NEW INDWELLING NEEDLE FOR THE PATIENT TO COMPLETE THE INFUSION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2022, THE NURSE IN THE NEUROLOGY WARD INJECTED AN INDWELLING NEEDLE FOR THE PATIENT, AND AFTER THE INDWELLING NEEDLE PUNCTURED INTO THE PATIENT'S SKIN, THE NURSE FOUND THAT THERE WAS BLOOD OOZING FROM THE TAIL OF THE PINTLE OF THE INDWELLING NEEDLE. THE NURSE WITHDRAWS AND SEALS UP THE BLEEDING INDWELLING NEEDLE, AND THEN PUNCTURES A NEW INDWELLING NEEDLE FOR THE PATIENT TO COMPLETE THE INFUSION.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146186 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2110383

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown