BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS YEL 24GA X 0.75IN PRN

    MDR report key: 16007140 · Received December 19, 2022

    Report

    Report Number
    3014704491-2022-00680
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 29, 2022
    Report Date
    January 9, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2140902. 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. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PEGASUS YEL 24GA X 0.75IN PRN THE NEEDLE COULD NOT BE DISENGAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE PUNCTURE WAS SUCCESSFUL WHEN THE INDWELLING NEEDLE WAS INJECTED, THE BLOOD RETURNED. WHEN THE NEEDLE CORE WAS READY TO BE PULLED OUT, IT WAS FOUND THAT IT COULD NOT BE PULLED OUT. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, HE HAD TO PULL IT OUT AND START AGAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PEGASUS YEL 24GA X 0.75IN PRN THE NEEDLE COULD NOT BE DISENGAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PUNCTURE WAS SUCCESSFUL WHEN THE INDWELLING NEEDLE WAS INJECTED, THE BLOOD RETURNED. WHEN THE NEEDLE CORE WAS READY TO BE PULLED OUT, IT WAS FOUND THAT IT COULD NOT BE PULLED OUT.AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, HE HAD TO PULL IT OUT AND START AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2589331 BD PEGASUS YEL 24GA X 0.75IN PRN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2140902

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown