BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS BL 22GA X 1.00IN QSYTE

    MDR report key: 8668548 · Received June 4, 2019

    Report

    Report Number
    3006948883-2019-00431
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 16, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 6231326. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE; UNFORTUNATELY WITHOUT THE ABILITY TO INSPECT THE AFFECTED UNIT, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PACKAGE WAS OPEN WITH A BD PEGASUS BL 22GA X 1.00IN QSYTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT'S FOUND THAT THE SINGLE UNIT PACKAGE WAS BROKEN WHEN GETTING THE PRODUCT OUT OF THE SHELF BOX. THE CATHETER WAS TILTED, WHICH CANNOT BE USED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 PACKAGE WAS OPEN WITH A BD PEGASUS BL 22GA X 1.00IN QSYTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT'S FOUND THAT THE SINGLE UNIT PACKAGE WAS BROKEN WHEN GETTING THE PRODUCT OUT OF THE SHELF BOX. THE CATHETER WAS TILTED, WHICH CANNOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459051 BD PEGASUS BL 22GA X 1.00IN QSYTE INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 6231326

    Patients

    Seq Age Sex Outcome Treatment
    1 Other