BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS PNK 20GA X 1.16IN PRN-CAP Y

    MDR report key: 11335726 · Received February 16, 2021

    Report

    Report Number
    3006948883-2021-00234
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    December 25, 2020
    Report Date
    March 10, 2021
    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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER: 9141633. 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, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. 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 PNK 20GA X 1.16IN PRN-CAP Y NEEDLE COULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, THE NURSE WAS PERFORMED PUNCTURING FOR PATIENT. DURING PUNCTURING PROCESS, THE NEEDLE COULDN'T DISENGAGE, AND IT CAUSED REPEATED PUNCTURING. AFTER REPLACEMENT, IT WENT NORMAL.

    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 PNK 20GA X 1.16IN PRN-CAP Y NEEDLE COULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, THE NURSE WAS PERFORMED PUNCTURING FOR PATIENT. DURING PUNCTURING PROCESS, THE NEEDLE COULDN'T DISENGAGE, AND IT CAUSED REPEATED PUNCTURING. AFTER REPLACEMENT, IT WENT NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229045 PEGASUS PNK 20GA X 1.16IN PRN-CAP Y CATHETER FOZ BD (SUZHOU) 9141633

    Patients

    Seq Age Sex Outcome Treatment
    1