BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANESTHESIA 17GAX18CM DURASAFE

    MDR report key: 11952672 · Received June 7, 2021

    Report

    Report Number
    3006948883-2021-00672
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    July 20, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMF
    PMA / PMN Number
    NA
    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: 2021-06-03. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0220527. 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. ADDITIONALLY ANALYSIS OF THE RETURNED SAMPLE REVEALED SURFACE ABRASIONS ON THE SURFACE OF THE SYRINGE BODY. THE ISSUE HAS BEEN CONFIRMED. BASED ON A REVIEW OF THE MANUFACTURING PROCESS OUR ENGINEERS HAVE DETERMINED THAT THE MOST LIKELY ROOT CAUSE IS RELATED TO THE SUPPLIED RAW MATERIAL. IN RESPONSE TO THIS EVENT OUR FACILITY HAS NOTIFIED OUR SUPPLIER OF THE ISSUE AND RETRAINED OUR INSPECTION TEAMS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ANESTHESIA 17GAX18CM DURASAFE PRODUCT WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OPERATING ROOM REPORTED THAT THE SYRINGE SYRINGE IN THE SACK PRODUCT WAS DAMAGED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ANESTHESIA 17GAX18CM DURASAFE PRODUCT WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OPERATING ROOM REPORTED THAT THE SYRINGE SYRINGE IN THE SACK PRODUCT WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846662 ANESTHESIA 17GAX18CM DURASAFE SYRINGE FMF BD (SUZHOU) 0220527

    Patients

    Seq Age Sex Outcome Treatment
    1