BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER

    MDR report key: 16773198 · Received April 19, 2023

    Report

    Report Number
    8041187-2023-00164
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 15, 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

    H3. 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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2082656. 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, A REVIEW WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT. THE UNITS WERE 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 PRN CAP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, WHEN THE NURSE WAS ABOUT TO USE THE INDWELLING NEEDLE, SHE DISASSEMBLED IT AND FOUND THAT THE HEPARIN CAP WAS MISSING, WHICH AFFECTED NORMAL USE. IT WAS REPLACED IN TIME AND THE EQUIPMENT DEPARTMENT WAS NOTIFIED TO DEAL WITH IT, AND NO ADVERSE EFFECTS WERE CAUSED TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS SAFETY CLOSED IV CATHETER PRN CAP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, WHEN THE NURSE WAS ABOUT TO USE THE INDWELLING NEEDLE, SHE DISASSEMBLED IT AND FOUND THAT THE HEPARIN CAP WAS MISSING, WHICH AFFECTED NORMAL USE. IT WAS REPLACED IN TIME AND THE EQUIPMENT DEPARTMENT WAS NOTIFIED TO DEAL WITH IT, AND NO ADVERSE EFFECTS WERE CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685711 BD PEGASUS SAFETY CLOSED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2082656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown