BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 10939347 · Received December 3, 2020

    Report

    Report Number
    3006948883-2020-00879
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 4, 2020
    Report Date
    January 6, 2021
    Manufacturer
    BD (SUZHOU)
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-29 H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0063010. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF FOREIGN MATERIAL 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. ALSO, THE AFFECTED WAS SUBMITTED BY THE FACILITY FOR EVALUATION; VISUAL OBSERVATION OF THE DEVICE WAS NOT ABLE TO IDENTIFY THE PRESENCE OF A FOREIGN MATERIAL, BUT OUR ENGINEERS DID MAKE NOTE OF A BEND IN THE CATHETER TUBING. FUNCTIONAL LEAKAGE WAS PERFORMED ON THE DEVICE TO DETERMINE IF THE FLUID WAS IMPEDED BY THE CREASE IN THE TUBING. THE RESULTS FROM THE TEST FOUND THE FLOW WAS NOT OBSTRUCTED OR OTHERWISE HINDERED. UNFORTUNATELY, WITHOUT THE ABILITY TO OBSERVE THE REPORTED NONCONFORMANCE BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THIS EVENT. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN FLUSHED THE TUBE FOR THE PATIENT, THE LIQUID WAS NOT FLOWED (IT CANNOT BE PUSHED). AFTER THE INDWELLING NEEDLE WAS PULLED OUT, IT WAS FOUND THAT THERE WAS AN UNKNOWN METAL OBJECT IN THE ROOT OF THE CATHETER TUBE. AT PRESENT, THE HOSPITAL HAD DOUBTS ABOUT THE PRODUCT QUALITY OF BD COMPANY, AND ORDERED THE COMPANY TO IDENTIFY IT AND ISSUED A WRITTEN REPORT ABOUT THE REASON DRUGS USED WITH THE DEVICE ARE CALF BLOOD, CEFOTIZOLE SODIUM, COMPOUND THREE-DIMENSIONAL B.

    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 EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN FLUSHED THE TUBE FOR THE PATIENT, THE LIQUID WAS NOT FLOWED (IT CANNOT BE PUSHED). AFTER THE INDWELLING NEEDLE WAS PULLED OUT, IT WAS FOUND THAT THERE WAS AN UNKNOWN METAL OBJECT IN THE ROOT OF THE CATHETER TUBE. AT PRESENT, THE HOSPITAL HAD DOUBTS ABOUT THE PRODUCT QUALITY OF BD COMPANY, AND ORDERED THE COMPANY TO IDENTIFY IT, AND ISSUED A WRITTEN REPORT ABOUT THE REASON. DRUGS USED WITH THE DEVICE ARE CALF BLOOD, CEFOTIZOLE SODIUM, COMPOUND THREE-DIMENSIONAL B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404811 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 0063010

    Patients

    Seq Age Sex Outcome Treatment
    1