BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3-PIECE SYRINGE

    MDR report key: 15135963 · Received July 29, 2022

    Report

    Report Number
    3003152976-2022-00340
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    June 28, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION: YES. D10: RETURNED TO MANUFACTURER ON: 02-AUG-2022 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTO, A HAIR WAS OBSERVED INSIDE THE BLISTER PACK. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2203036, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE ROOT CAUSE OF THIS INCIDENT IS DUE TO PERSONNEL NOT FOLLOWING THE PROPER GOWNING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAIR WAS FOUND IN THE BD PLASTIPAK¿ 3-PIECE SYRINGE UNIT PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DARK HAIR IN THE PACKAGE. THERE IS NO CHANCE THAT THE HAIR HAS GOTTEN THERE AFTER OPENING THE SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAIR WAS FOUND IN THE BD PLASTIPAK¿ 3-PIECE SYRINGE UNIT PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DARK HAIR IN THE PACKAGE. THERE IS NO CHANCE THAT THE HAIR HAS GOTTEN THERE AFTER OPENING THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951455 BD PLASTIPAK¿ 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown