BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 16742884 · Received April 14, 2023

    Report

    Report Number
    8041187-2023-00158
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    February 16, 2023
    Report Date
    April 24, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903837120
    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

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2110472. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THE 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM DEFECTIVE TUBING LED TO LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6)2023, THE NURSE WAS GOING TO INDWELL THE PATIENT WITH AN INDWELLING NEEDLE. THE NURSE FOUND NO ABNORMALITY AFTER UNPACKING THE INDWELLING NEEDLE, AND THERE WAS NO OBVIOUS PROBLEM WITH THE INDWELLING NEEDLE PIPELINE. AFTER INDWELLING CATHETER, IT WAS FOUND THAT THE INDWELLING NEEDLE WAS LEAKING BLOOD. AFTER CAREFUL INSPECTION, IT WAS FOUND THAT THE INDWELLING NEEDLE WAS DAMAGED. THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED, THE WOUND WAS PRESSED, AND THE INDWELLING NEEDLE WAS REPLACED AGAIN. THE NURSE OPERATED ACCORDING TO THE NORMAL PROCEDURE, AND NO SHARP OBJECTS WERE ENCOUNTERED DURING THE OPERATION. THE MEDICAL ENGINEERING DEPARTMENT JUDGED THAT THERE WAS A QUALITY PROBLEM WITH THE INDWELLING NEEDLE. THE DEPARTMENT OF MEDICAL ENGINEERING INFORMED THE USER DEPARTMENT TO PAY ATTENTION TO THE USE OF THE BATCH OF INDWELLING NEEDLES, AND REPORT ANY PROBLEMS FOUND IN TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM DEFECTIVE TUBING LED TO LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2023, THE NURSE WAS GOING TO INDWELL THE PATIENT WITH AN INDWELLING NEEDLE. THE NURSE FOUND NO ABNORMALITY AFTER UNPACKING THE INDWELLING NEEDLE, AND THERE WAS NO OBVIOUS PROBLEM WITH THE INDWELLING NEEDLE PIPELINE. AFTER INDWELLING CATHETER, IT WAS FOUND THAT THE INDWELLING NEEDLE WAS LEAKING BLOOD. AFTER CAREFUL INSPECTION, IT WAS FOUND THAT THE INDWELLING NEEDLE WAS DAMAGED. THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED, THE WOUND WAS PRESSED, AND THE INDWELLING NEEDLE WAS REPLACED AGAIN. THE NURSE OPERATED ACCORDING TO THE NORMAL PROCEDURE, AND NO SHARP OBJECTS WERE ENCOUNTERED DURING THE OPERATION. THE MEDICAL ENGINEERING DEPARTMENT JUDGED THAT THERE WAS A QUALITY PROBLEM WITH THE INDWELLING NEEDLE. THE DEPARTMENT OF MEDICAL ENGINEERING INFORMED THE USER DEPARTMENT TO PAY ATTENTION TO THE USE OF THE BATCH OF INDWELLING NEEDLES, AND REPORT ANY PROBLEMS FOUND IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901371 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2110472 00382903837120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown