BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC

    MDR report key: 10659821 · Received October 9, 2020

    Report

    Report Number
    3006948883-2020-00508
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 15, 2020
    Report Date
    November 16, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    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 9232305 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC WAS DEFECTIVE AND DAMAGED THE PATIENT'S SKIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INPATIENT REQUIRED FLUID INFUSION FOR PULMONARY INFECTION. THE PATIENT'S SKIN WAS DAMAGED BECAUSE THE INDWELLING NEEDLE WAS COARSED FOR INFUSION AND FAILED TO DELIVER THE NEEDLE. SO THE NEW INDWELLING NEEDLE WAS REPLACED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC WAS DEFECTIVE AND DAMAGED THE PATIENT'S SKIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INPATIENT REQUIRED FLUID INFUSION FOR PULMONARY INFECTION. THE PATIENT'S SKIN WAS DAMAGED BECAUSE THE INDWELLING NEEDLE WAS COARSED FOR INFUSION AND FAILED TO DELIVER THE NEEDLE. SO THE NEW INDWELLING NEEDLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123989 PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC CATHETER FOZ BD (SUZHOU) 9232305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other