BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK SYRINGE

    MDR report key: 16010537 · Received December 19, 2022

    Report

    Report Number
    1911916-2022-00761
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    October 17, 2022
    Report Date
    February 5, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH POSSIBLE INFORMATION: D4: MEDICAL DEVICE LOT #: 1106460 . D4: MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2026. H4: DEVICE MANUFACTURE DATE: 30-JUN-2021. D4: MEDICAL DEVICE LOT #: 1180050. D4: MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026. H4: DEVICE MANUFACTURE DATE: 19-MAY-2021. H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS FOREIGN DEBRIS INSIDE THE SYRINGE. AS A 50ML SYRINGE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, POSSIBLE LOTS 1106460 AND 1180050. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ LUER-LOK SYRINGE EXPERIENCED FOREIGN DEBRIS INSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY HAD A CUSTOMER REPORT OF FINDING ¿FOREIGN DEBRIS¿ INSIDE A SYRINGE, BD 301035, THAT WAS PROVIDED TO THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ LUER-LOK SYRINGE EXPERIENCED FOREIGN DEBRIS INSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY HAD A CUSTOMER REPORT OF FINDING ¿FOREIGN DEBRIS¿ INSIDE A SYRINGE, BD 301035, THAT WAS PROVIDED TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588497 BD¿ LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown