BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SF SALINE SYRINGE

    MDR report key: 16251427 · Received January 26, 2023

    Report

    Report Number
    9616657-2023-00004
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 4, 2023
    Report Date
    March 2, 2023
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065530
    PMA / PMN Number
    K042061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306553 AND LOT NUMBER 2200564. THE REVIEW DID NOT REVEAL ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. AS NEITHER A PICTURE SAMPLE NOR A PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION, OUR QUALITY ENGINEER TEAM COULD NOT COMPLETE A THOROUGH SAMPLE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SF SALINE SYRINGE WAS "MELTED". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A MELTED SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SF SALINE SYRINGE WAS "MELTED". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A MELTED SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411358 BD POSIFLUSH¿ SF SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 2200564 00382903065530

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown