BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ - 3-PIECE SYRINGE

    MDR report key: 16016805 · Received December 20, 2022

    Report

    Report Number
    3003152976-2022-00572
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    December 1, 2022
    Report Date
    January 20, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 02-JAN-2023. H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A POLYPROPYLENE PARTICLE WAS OBSERVED INSIDE THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2210019, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED FOREIGN MATTER IN DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 28/11/22, WHILE PULLING UP RITUXIMAB SC 1400MG IN A 20ML BD SYRINGE (LOT 2210019 AND EXP 30/09/2027), WE NOTICED A PARTICLE STUCK ON THE INSIDE OF THE SYRINGE. AS A PRECAUTION, WE DID NOT DELIVER AND ADMINISTER THIS MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED FOREIGN MATTER IN DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2022, WHILE PULLING UP RITUXIMAB SC 1400MG IN A 20ML BD SYRINGE (LOT 2210019 AND EXP 30/09/2027), WE NOTICED A PARTICLE STUCK ON THE INSIDE OF THE SYRINGE. AS A PRECAUTION, WE DID NOT DELIVER AND ADMINISTER THIS MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588548 BD PLASTIPAK ¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2210019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown