BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC

    MDR report key: 8600504 · Received May 10, 2019

    Report

    Report Number
    3006948883-2019-00361
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 23, 2019
    Report Date
    June 11, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233211. 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. SAMPLES WERE SUBMITTED FOR EVALUATION; BD ENGINEERS WERE ABLE TO OBSERVE A DAMAGE TO THE V-CLIP DURING THE VISUAL OBSERVATION OF THE DEVICE. THE ROOT CAUSE FOR THIS OCCURRENCE MOST LIKELY DUE TO A MISSING PIN IN THE MANUFACTURING MACHINERY THAT LEAD TO A MISALIGNMENT DURING ASSEMBLY. TO ADDRESS THIS ISSUE WE HAVE REPAIRED THE DAMAGED EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC EXPERIENCED SAFETY FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DATE: (B)(6) 2019. THE NURSE FOUND THAT THE SAFETY SHIELD CANNOT BE REMOVED AFTER PENETRATION.

    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 PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC EXPERIENCED SAFETY FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DATE: (B)(6) 2019; THE NURSE FOUND THAT THE SAFETY SHIELD CANNOT BE REMOVED AFTER PENETRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391714 PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC IV CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8233211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other