BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 11033220 · Received December 17, 2020

    Report

    Report Number
    8041187-2020-00849
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 5, 2020
    Report Date
    January 13, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9173717. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WAS DEFECTIVE AND THE INDWELLING TROCAR SEPARATED FROM THE NEEDLE CORE WHEN REMOVING IT FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "AT 14:00 ON (B)(6), 2020, THE NURSE IN CHARGE PLACED A CLOSED ANTI-NEEDLE-STICK TYPE INTRAVENOUS INDWELLING NEEDLE FOR THE PATIENT, AND FOUND THAT THE PUNCTURE RESISTANCE WAS HIGH AND THE PATIENT FELT UNBEARABLE PAIN. AFTER THE REMOVAL OF THE INDWELLING NEEDLE, THE INDWELLING TROCAR WAS SEPARATED FROM THE NEEDLE CORE, CAUSING THE PATIENT TO GET A SECOND INJECTION. REPLACE THE INDWELLING NEEDLE"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WAS DEFECTIVE AND THE INDWELLING TROCAR SEPARATED FROM THE NEEDLE CORE WHEN REMOVING IT FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AT 14:00 ON (B)(6) 2020, THE NURSE IN CHARGE PLACED A CLOSED ANTI-NEEDLE-STICK TYPE INTRAVENOUS INDWELLING NEEDLE FOR THE PATIENT, AND FOUND THAT THE PUNCTURE RESISTANCE WAS HIGH AND THE PATIENT FELT UNBEARABLE PAIN. AFTER THE REMOVAL OF THE INDWELLING NEEDLE, THE INDWELLING TROCAR WAS SEPARATED FROM THE NEEDLE CORE, CAUSING THE PATIENT TO GET A SECOND INJECTION. REPLACE THE INDWELLING NEEDLE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497241 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9173717

    Patients

    Seq Age Sex Outcome Treatment
    1