BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 10488068 · Received September 3, 2020

    Report

    Report Number
    3003152976-2020-00395
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1911732, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1911732 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, THE STOPPER WAS PROPERLY ASSEMBLED ONTO THE PLUNGER ROD, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE LEAKED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "HERE, FLUID RUNS OVER THE RUBBER STOPPER INTO THE SPACE BETWEEN THE PLUNGER AND CYLINDER."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER FAX#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE LEAKED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "HERE, FLUID RUNS OVER THE RUBBER STOPPER INTO THE SPACE BETWEEN THE PLUNGER AND CYLINDER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950987 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1911732

    Patients

    Seq Age Sex Outcome Treatment
    1 Other