BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK 1-ML SYRINGE

    MDR report key: 12437152 · Received September 7, 2021

    Report

    Report Number
    1213809-2021-00618
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1110976. D4: MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. H4: DEVICE MANUFACTURE DATE: 2021-06-07. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-31. INVESTIGATION SUMMARY: ONE 1ML LUER LOCK SYRINGE (P/N 309628) INSIDE A PARTIALLY OPENED BLISTERPAK FROM BATCH #1110976 WAS RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED WITH NO DEFECTS PRESENT. THE SAMPLE WAS TESTED FOR LEAKAGE AT THE LUER CONNECTION. THE SYRINGE DID NOT LEAK AND WAS ACCEPTABLE PER PRODUCT SPECIFICATION. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ 1-ML SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE SYRINGE LEAKED. ".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 BD LUER-LOK¿ 1-ML SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE SYRINGE LEAKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329871 BD LUER-LOK 1-ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 1110976 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1