BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8976139 · Received September 9, 2019

    Report

    Report Number
    3006948883-2019-00742
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 9, 2019
    Report Date
    October 3, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    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 9050864. 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. 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 AFTER SUCCESSFUL INSERTION AFTER 40 MINUTES IT WAS DISCOVERED THE PATIENT HAD LIFTED LIMB AND IT WAS DISCOVER THE TUBING WAS BROKEN WITH A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AT 19:20 ON (B)(6) 2019, THE PATIENT'S INDWELLING NEEDLE WAS OBSERVED ON THE BACK OF THE RIGHT LOWER EXTREMITY. THE IN-POSITION WAS WELL FIXED, THE INDWELLING PIN STRIP WAS NOT TWISTED, AND THERE WAS NO PULLING, AND THE INFUSION COULD BE PERFORMED NORMALLY. AT 20:00, THE PATIENT WAS FOUND TO HAVE A SLIGHTLY LIFTED LIMB MOVEMENT. WHEN THE PATIENT WAS OBSERVED, HE WAS FOUND TO HAVE BROKEN THE NEEDLE STRIP INTO TWO SECTIONS, AND IMMEDIATELY STOPPED REHYDRATION, AND THEN RE-ADMINISTERED THE INDWELLING NEEDLE PUNCTURE REHYDRATION TREATMENT. AFTER THE OBSERVATION, THE RUPTURE INDWELLING NEEDLE PUNCTURE SITE, NO REDNESS, HEAT, PAIN, EXTRAVASATION, ETC.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 AFTER SUCCESSFUL INSERTION AFTER 40 MINUTES IT WAS DISCOVERED THE PATIENT HAD LIFTED LIMB AND IT WAS DISCOVER THE TUBING WAS BROKEN WITH A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AT 19:20 ON (B)(6) 2019, THE PATIENT'S INDWELLING NEEDLE WAS OBSERVED ON THE BACK OF THE RIGHT LOWER EXTREMITY. THE IN-POSITION WAS WELL FIXED, THE INDWELLING PIN STRIP WAS NOT TWISTED, AND THERE WAS NO PULLING, AND THE INFUSION COULD BE PERFORMED NORMALLY. AT 20:00, THE PATIENT WAS FOUND TO HAVE A SLIGHTLY LIFTED LIMB MOVEMENT. WHEN THE PATIENT WAS OBSERVED, HE WAS FOUND TO HAVE BROKEN THE NEEDLE STRIP INTO TWO SECTIONS, AND IMMEDIATELY STOPPED REHYDRATION, AND THEN RE-ADMINISTERED THE INDWELLING NEEDLE PUNCTURE REHYDRATION TREATMENT. AFTER THE OBSERVATION, THE RUPTURE INDWELLING NEEDLE PUNCTURE SITE, NO REDNESS, HEAT, PAIN, EXTRAVASATION, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771604 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9050864

    Patients

    Seq Age Sex Outcome Treatment
    1 Other