BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 14739397 · Received June 17, 2022

    Report

    Report Number
    1213809-2022-00345
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 14, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1046054. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026. DEVICE MANUFACTURE DATE: 15-FEB-2021. MEDICAL DEVICE LOT #: 1159716. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026. DEVICE MANUFACTURE DATE: 08-JUN-2021. MEDICAL DEVICE LOT #: 1252313. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026. DEVICE MANUFACTURE DATE: 09-SEP-2021. MEDICAL DEVICE LOT #: 1312499. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026. DEVICE MANUFACTURE DATE: 08-NOV-2021. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 24-JUN-2022. THE CUSTOMER PROVIDED AN ADDITIONAL LOT#. THE FOLLOWING FIELDS HAVE BEEN UPDATED: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1046054, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026, H.4. DEVICE MANUFACTURE DATE: 15-FEB-2021. D.4. MEDICAL DEVICE LOT #: 1159716, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026, H.4. DEVICE MANUFACTURE DATE: 08-JUN-2021. D.4. MEDICAL DEVICE LOT #: 1252313, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026, H.4. DEVICE MANUFACTURE DATE: 09-SEP-2021. D.4. MEDICAL DEVICE LOT #: 1312499, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026, H.4. DEVICE MANUFACTURE DATE: 08-NOV-2021. D.4. MEDICAL DEVICE LOT #: 0345362, D.4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2025, H.4. DEVICE MANUFACTURE DATE: 10-DEC-2020. INVESTIGATION: H.6. INVESTIGATION SUMMARY: THREE SAMPLES FOR LOT 1046054, ONE SAMPLE FOR LOT 1159716, AND FORTY-ONE SAMPLES FOR LOT 1312499 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SAMPLES HAD MINOR PRESENCE OF SILICONE ON THE STOPPER. ALL SAMPLES INSPECTED WERE ACCEPTABLE PER PRODUCT SPECIFICATION. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. DEVICE HISTORY RECORD REVIEWS WERE COMPLETED FOR PROVIDED LOT NUMBERS 1046054, 1159716, 1252313, 1312499, AND 0345362. THE REVIEWS SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: IT IS A SHINY SUBSTANCE PARTIALLY PRESENT ON THE SURFACE AND/OR EDGES OF THE BLACK RUBBER OF THE PLUNGER, REMINISCENT OF A LUBRICANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: IT IS A SHINY SUBSTANCE PARTIALLY PRESENT ON THE SURFACE AND/OR EDGES OF THE BLACK RUBBER OF THE PLUNGER, REMINISCENT OF A LUBRICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202449 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 SEE SECTION H10 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown