BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS GN 18GAX1.16IN DUAL

    MDR report key: 11206301 · Received January 21, 2021

    Report

    Report Number
    3006948883-2021-00150
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 29, 2020
    Report Date
    February 15, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-01-08. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9023779. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A BROKEN NEEDLE 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. ADDITIONALLY OUR ENGINEERS REVIEWED THE DEVICE SUBMITTED BY THE FACILITY. THEY NOTED THAT THE PROTECTIVE NEEDLE COVERING WAS PRESENT BUT BENT, AND THE NEEDLE CORE HAD FRACTURED. A REVIEW OF THE MANUFACTURING FACILITY WAS PERFORMED AND EVIDENCE OF A MISALIGNMENT WAS FOUND IN THE AUTOMATED ASSEMBLY PROCESS. TO PREVENT FUTURE OCCURRENCES OF THIS ISSUE OUR FACILITY HAS STOPPED USING THE AUTOMATED STATION RESPONSIBLE FOR NEEDLE COVER INSTALLATION UNTIL THE APPROPRIATE MEASURES CAN BE TAKEN TO OPTIMIZE PERFORMANCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PEGASUS¿ GN 18GAX1.16IN DUAL THE NEEDLE WAS DISCOVERED TO BE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE OPENED THE PACKAGE FOR THE FIRST PUNCTURE AND FOUND THAT THE HAND FEEL WAS ABNORMAL, SHE IMMEDIATELY STOPPED THE PUNCTURE AND THEN OBSERVED AND FOUND THAT THE STEEL NEEDLE WAS IN A BROKEN STATE IN THE CATHETER TUBING.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD PEGASUS¿ GN 18GAX1.16IN DUAL THE NEEDLE WAS DISCOVERED TO BE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN THE NURSE OPENED THE PACKAGE FOR THE FIRST PUNCTURE AND FOUND THAT THE HAND FEEL WAS ABNORMAL, SHE IMMEDIATELY STOPPED THE PUNCTURE AND THEN OBSERVED AND FOUND THAT THE STEEL NEEDLE WAS IN A BROKEN STATE IN THE CATHETER TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106676 BD PEGASUS GN 18GAX1.16IN DUAL INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9023779

    Patients

    Seq Age Sex Outcome Treatment
    1