BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14658884 · Received June 10, 2022

    Report

    Report Number
    3003152976-2022-00260
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 16, 2022
    Report Date
    July 27, 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2203079, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027, DEVICE MANUFACTURE DATE: 17-MAR-2022. MEDICAL DEVICE LOT #: 2203016, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027, DEVICE MANUFACTURE DATE: 07-MAR-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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 30-MAY-2022. 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 2203016, 2203079, 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 THAT 1 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EACH FROM LOTS 2203079 AND 2203016 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "SYRINGE EMPTIES BY GRAVITY, THIS MEANS THAT THE SYRINGE IS LEAKING. DID THE DEFECT AFFECT ANY PATIENT? IN THIS CASE, THE DEFECT WAS DISCOVERED IN TIME BY THE NURSE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EACH FROM LOTS 2203079 AND 2203016 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "SYRINGE EMPTIES BY GRAVITY, THIS MEANS THAT THE SYRINGE IS LEAKING. DID THE DEFECT AFFECT ANY PATIENT? IN THIS CASE, THE DEFECT WAS DISCOVERED IN TIME BY THE NURSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289336 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown