BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CONTROL 10ML LL BNS

    MDR report key: 9511405 · Received December 23, 2019

    Report

    Report Number
    1213809-2019-01296
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 3, 2019
    Report Date
    February 3, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    MATERIAL NO. 304134. BATCH NO. 9112830. IT WAS REPORTED THAT THE SYRINGE CONTROL 10ML LL BNS HAS A CUT ON THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER, THE THREE RING SYRINGE HAS A CUT IN IT."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 304134, BATCH NO. 9112830. IT WAS REPORTED THAT THE SYRINGE CONTROL 10ML LL BNS HAS A CUT ON THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER, THE THREE RING SYRINGE HAS A CUT IN IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309004 SYRINGE CONTROL 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9112830

    Patients

    Seq Age Sex Outcome Treatment
    1 Other