BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 13893273 · Received March 24, 2022

    Report

    Report Number
    9616657-2022-00007
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 10, 2022
    Report Date
    April 14, 2022
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 1222657. THERE WAS ONE NON-CONFORMANCE DURING THE PRODUCTION OF THIS LOT RELATED TO DAMAGED BARRELS. IN RESPONSE TO THE DETECTION OF THIS NON-CONFORMANCE, AN INVESTIGATION WAS COMPLETED AND ALL OF THE AFFECTED MATERIAL WAS SCRAPPED. IT WAS DETERMINED THAT THE NON-CONFORMANCE WAS AN ISOLATED EVENT. AS NEITHER THE PHYSICAL SAMPLE NOR A PICTURE SAMPLE WAS AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A LARGE PIECE OF PLASTIC IN THE POSIFLUSH NORMAL SALINE SYRINGE 10 ML.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A LARGE PIECE OF PLASTIC IN THE POSIFLUSH NORMAL SALINE SYRINGE 10 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881217 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 306546 1222657 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown