BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11638797 · Received April 8, 2021

    Report

    Report Number
    3003152976-2021-00188
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A TOTAL OF THREE SAMPLES OF LOT 2010091 WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION, TWO ASSOCIATED WITH ANOTHER COMPLAINT. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED IN BOTH SAMPLES. ONE SAMPLE WAS INDICATED TO BE CHEMO CONTAMINATED AND COULD ONLY UNDERGO A VISUAL EVALUATION. THERE WAS NO VISIBLE DAMAGE OR MOLDING DEFECTS NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE LEAKAGE OBSERVED. THE SECOND PRODUCT WAS FURTHER EVALUATED AND DAMAGE WAS OBSERVED ON THE SYRINGE BARREL WHICH CAN RESULT IN A LEAKAGE WHEN USING THE PRODUCT . A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE LOT 2010091, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS, HOWEVER, A DAILY INCIDENT REPORT DID IDENTIFY AN ISSUE OF BARRELS JAMMING WITHIN THE ASSEMBLY MACHINE WHICH COULD HAVE CONTRIBUTED TO THE DAMAGE OBSERVED ON THE ONE BARREL. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING TIGHTNESS TESTING TO VERIFY THE STOPPER SEAL. RESULTS WERE REVIEWED FOR THE LOT 2010091 AND NO ISSUES WERE IDENTIFIED. BASED ON OUR QUALITY TEAM'S INVESTIGATION AND SAMPLE EVALUATION, IT APPEARS THE ONE LEAK WAS RELATED TO THE DAMAGE ON THE BARREL WHICH LIKELY OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED WATER WHILE PULLING UP "API" FROM A VIAL. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "WHEN PULLING UP API FROM A VIAL INTO THE SYRINGE, WATER RAN DOWN THE PESTLE. WITH OTHER SYRINGE AND SAME VIAL AND SAME CHEMFORT ADAPTOR THE PROBLEM DID NOT OCCUR. SO THE FAULT IS PROBABLY IN THE SYRINGE.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED WATER WHILE PULLING UP "API" FROM A VIAL. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN PULLING UP API FROM A VIAL INTO THE SYRINGE, WATER RAN DOWN THE PESTLE. WITH OTHER SYRINGE AND SAME VIAL AND SAME CHEMFORT ADAPTOR THE PROBLEM DID NOT OCCUR. SO THE FAULT IS PROBABLY IN THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532280 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010091

    Patients

    Seq Age Sex Outcome Treatment
    1