BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS/SF

    MDR report key: 22494932 · Received July 14, 2025

    Report

    Report Number
    9616657-2025-00013
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 21, 2025
    Report Date
    September 9, 2025
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065530
    PMA / PMN Number
    K153481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, FIVE (5) PICTURE SAMPLES AND FOUR (4) PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, BROWN STAINING WAS OBSERVED ON THE BLISTER PACKAGING. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306553 AND LOT NUMBER 5023049. THE REVIEW REVEALED TWO (2) NON-CONFORMANCES DURING THE PRODUCTION PROCESS FOR FOREIGN MATTER. THE FOREIGN MATTER WAS RELATED TO BROWN STAINING ON THE XS PACKAGING FROM THE STERILIZER. PRODUCT WAS HELD, SAMPLED, AND RELEASED BASED ON PASSING THE SAMPLING PROCEDURES. THE BROWNISH SPOTS ON THE PACKAGING CAN OCCUR DURING THE STEAM STERILIZATION PROCESS. THIS IS A COSMETIC DEFECT ONLY AND THE INTEGRITY OF THE PRODUCT AND THE STERILE BARRIERS IS NOT AFFECTED. FURTHERMORE, MICROBIAL PERMEABILITY TESTING, CYTOTOXICITY TESTING, AND TESTING FOR RESIDUAL SOLVENTS AND VOLATILE SPECIES HAS BEEN COMPLETED ON PACKAGES DISPLAYING THE BROWNISH STAIN. THE TESTING CONFIRMED THAT THEY DO NOT PRESENT ANY RISK TO THE USE OF THE PRODUCT AND HAVE NO IMPACT ON THE EFFECTIVENESS, STERILITY, QUALITY OR SAFETY OF BD POSIFLUSH¿ 10 ML SALINE FLUSH SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH-XS / SF FOREIGN MATTER IN THE PACKAGE SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE BEING UTILIZED IN PRODUCTION, IT WAS NOTED THAT 7 EACHES OF ITEM 306553, LOT 5023049 HAD DEBRIS VISIBLE IN THE SYRINGE AND SYRINGE SEAL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046506 BD POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 5023049 00382903065530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown