BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 15136403 · Received July 29, 2022

    Report

    Report Number
    3003152976-2022-00342
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    June 30, 2022
    Report Date
    August 19, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2112017. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2026. DEVICE MANUFACTURE DATE: 02-DEC-2021. MEDICAL DEVICE LOT #: 2108041. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026. DEVICE MANUFACTURE DATE: 25-AUG-2021. MEDICAL DEVICE LOT #: 2112028. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2026. DEVICE MANUFACTURE DATE: 15-DEC-2021. MEDICAL DEVICE LOT #: 2202024. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. DEVICE MANUFACTURE DATE: 10-FEB-2022. 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

    H6: INVESTIGATION SUMMARY: MULTIPLE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WAS OBSERVED AND ALL SYRINGES WERE PROPERLY ASSEMBLED. PRODUCT WAS DISASSEMBLED FOR FURTHER EVALUATION, NO DEFECTS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 2112017, 2108041, 2112028 AND 2202024, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FUNCTIONAL TESTING WAS PERFORMED ON THE PRODUCTS, FILLING SAMPLES FROM EACH LOT WITH WATER. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGES WERE OBSERVED FROM THE TIP OR PAST THE STOPPER. DIMENSIONAL EVALUATIONS WERE ALSO PERFORMED, VERIFYING THE TIPS ON ALL PRODUCT WAS WITHIN REQUIRED SPECIFICATIONS. BASED ON OUR INVESTIGATION AND SAMPLE EVALUATION, NO DEFECTS OR LEAKAGES WERE OBSERVED, AND DEVICE RECORDS DID NOT INDICATE ANY ISSUES RELATED TO THE REPORTED EVENT, THEREFORE, WE CANNOT IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED FOR TIMES THAT WHILE USING A BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE, LEAKAGE WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE EMPTIES BY GRAVITY.

    Description of Event or Problem · 0

    IT WAS REPORTED FOR TIMES THAT WHILE USING A BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE, LEAKAGE WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE EMPTIES BY GRAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411914 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown