BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 9695264 · Received February 11, 2020

    Report

    Report Number
    3003152976-2020-00052
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 21, 2020
    Report Date
    March 6, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1905240. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. H.4. DEVICE MANUFACTURE DATE: 2019-05-22 . D.4. MEDICAL DEVICE LOT #: 1905216. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. H.4. DEVICE MANUFACTURE DATE: 2019-05-03. H.6. INVESTIGATION: 120 SAMPLES OF LOT 1905240 AND 60 SAMPLES OF LOT 1905216 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PRODUCTS, NO LEAKAGES WERE OBSERVED. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, THERE WAS NO DAMAGE NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAK. AS NO SAMPLES OF LOT 1901247 WERE PROVIDED, TEN RETAINED SAMPLES OF THIS LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, AGAIN NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE LOTS 1901247, 1905240 AND 1905216, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PAST THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "174 SYRINGES WHERE LEAKAGE WAS OBSERVED AT THE PLUNGER ROD."

    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 THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PAST THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "174 SYRINGES WHERE LEAKAGE WAS OBSERVED AT THE PLUNGER ROD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160354 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other