BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 10098952 · Received May 28, 2020

    Report

    Report Number
    8041187-2020-00288
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    March 21, 2020
    Report Date
    June 29, 2020
    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

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8012107. 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 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 SYSTEM TUBE WAS FOUND DAMAGED DURING USE AFTER DISCOVERING THE PATIENTS SHEETS WERE WET DURING THE FLUID REHYDRATION PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON (B)(6) 2020, THE PATIENT WAS GIVEN PUNCTURING WITH INDWELLING NEEDLE. ON THE NEXT DAY, THE SHEET WAS FOUND TO BE WET DURING FLUID REHYDRATION, AFTER CHECKING BY THE NURSE, THE TUBE OF THE INDWELLING NEEDLE WAS DAMAGED, SO IT WAS REPLACED IMMEDIATELY."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM TUBE WAS FOUND DAMAGED DURING USE AFTER DISCOVERING THE PATIENTS SHEETS WERE WET DURING THE FLUID REHYDRATION PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2020, THE PATIENT WAS GIVEN PUNTURING WITH INDWELLING NEEDLE. ON THE NEXT DAY, THE SHEET WAS FOUND TO BE WET DURING FLUID REHYDRATION, AFTER CHECKING BY THE NURSE, THE TUBE OF THE INDWELLING NEEDLE WAS DAMAGED, SO IT WAS REPLACED IMMEDIATELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558605 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8012107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other