BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 13996221 · Received April 4, 2022

    Report

    Report Number
    3003152976-2022-00133
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    February 14, 2022
    Report Date
    May 5, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. LOT NUMBER WAS NOT REPORTED; HOWEVER, A POTENTIAL LOT NUMBER WAS PROVIDED. THE INFORMATION FOR THAT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2111091. MEDICAL DEVICE EXPIRATION DATE: 31OCT2026. DEVICE MANUFACTURE DATE: 10NOV2021. 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

    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 SUSPECTED LOT 2111091, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2111091 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, THE STOPPERS WERE PROPERLY ASSEMBLED, AND NO LEAKS WERE IDENTIFIED DURING TESTING. 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 WHILE USING BD PLASTIPAK¿ SYRINGES LEAKAGE OCCURRED BEHIND THE STOPPER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF ANTICANCER AGENT THAT PASSES UNDER THE PLUNGER OF THE SYRINGE DURING THE PREPARATION OF ANTICANCER CHEMOTHERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES LEAKAGE OCCURRED BEHIND THE STOPPER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF ANTICANCER AGENT THAT PASSES UNDER THE PLUNGER OF THE SYRINGE DURING THE PREPARATION OF ANTICANCER CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81974 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown