BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 10130770 · Received June 8, 2020

    Report

    Report Number
    8041187-2020-00327
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 13, 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

    INVESTIGATION SUMMARY; A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7142462. 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'S TUBING CLAMP WAS DEFECTIVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6), THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO 41-WEEK GESTATION AND DELIVERED. WHEN USING THE CLOSED ANTI-PIN PUNCTURE INTRAVENOUS INDWELLING NEEDLE PRODUCT, THE PATIENT STILL EXPERIENCED REFLUX AFTER CLAMPING, AND THE NEEDLE WAS IMMEDIATELY REPLACED AND DISPOSED WITHOUT CAUSING ANY INJURY TO THE PATIENT.

    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'S TUBING CLAMP WAS DEFECTIVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ON (B)(6), THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO 41-WEEK GESTATION AND DELIVERED. WHEN USING THE CLOSED ANTI-PIN PUNCTURE INTRAVENOUS INDWELLING NEEDLE PRODUCT, THE PATIENT STILL EXPERIENCED REFLUX AFTER CLAMPING, AND THE NEEDLE WAS IMMEDIATELY REPLACED AND DISPOSED WITHOUT CAUSING ANY INJURY TO THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590861 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7142462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other