BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 8506004 · Received April 11, 2019

    Report

    Report Number
    3003152976-2019-00264
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 27, 2019
    Report Date
    April 29, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 1812222, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 11812222 WERE USED TO CONDUCT LEAKAGE TESTS. 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 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 LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN SAMPLING A CYTOSTATIC PRODUCT WITH A 50ML LL SYRINGE REF (B)(4), LOT 1812222, LIQUID WAS FOUND "IN THE BLACK TIP OF THE PLUNGER"; BETWEEN THE TWO "RINGS"."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). 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 LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN SAMPLING A CYTOSTATIC PRODUCT WITH A 50ML LL SYRINGE REF 300865, LOT 1812222, LIQUID WAS FOUND "IN THE BLACK TIP OF THE PLUNGER"; BETWEEN THE TWO "RINGS"."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297750 BD PLASTIPAK 50ML LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1812222 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other