BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS/SF

    MDR report key: 22613193 · Received July 25, 2025

    Report

    Report Number
    9616657-2025-00014
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    May 1, 2025
    Report Date
    July 25, 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
    505

    Narratives

    Additional Manufacturer Narrative · 0

    PACKAGING DAMAGE/STERILITY CONCERN IDENTIFIED DURING INVESTIGATION AND DOES NOT APPEAR IN THE CUSTOMER COMPLAINT WHICH WAS NOT MDR REPORTABLE. DEVICE EVALUATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306553 AND LOT NUMBER 4256173 AND 4250495. THE REVIEW DID NOT REVEAL ANY POSSIBLE DETECTED NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES AND SEVEN (7) PHYSICAL SAMPLES FOR REPORTED LOT NUMBER 4256173 WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, PACKAGE DAMAGE AND FOREIGN MATTER WERE IDENTIFIED. 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¿ 10ML SALINE FLUSH SYRINGE. A REVIEW WAS COMPLETED WITH THE TECHNICAL TEAM TO DETERMINE THE ROOT CAUSE OF THE PACKAGE DAMAGE (TEAR IN TOP WEB) FOLLOWING THE INVESTIGATION. THE TECHNICAL TEAM DETERMINED THAT THE ROOT CAUSE WAS MOST LIKELY A CRASH IN THE MANUFACTURING MACHINERY WHERE THE FLANGE OF THE BARREL WAS PUSHED INTO THE PAPER WEB CAUSING THE BREAK. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE SEE THE ATTACHED NOTIFICATION IN REFERENCE TO MULTIPLE LOTS OF ITEM 306553. WHILE BEING UTILIZED ON THE PRODUCTION LINE, IT WAS NOTED THE LOTS 4256173, 5006316, AND 4250495 OF ITEM 306553 ALL HAD YELLOWING AND YELLOW SPOTS ON THE LABELS OF THE SYRINGES. EACH LOT FAILED SAMPLING. AS ALL LOTS IN HOUSE WERE AFFECTED BY THIS, MAI MADE THE DECISION TO SORT THE PRODUCT FOR USE. THE AMOUNT OF AFFECTED SYRINGES ARE LISTED BY LOT IN THE ATTACHED AND BELOW. PLEASE PROVIDE AN RTV FOR THESE COMPONENTS AS WE ARE UNABLE TO USE THEM. WE ARE HAPPY TO SEND SAMPLES IF YOU PROVIDE SHIPPING INFORMATION. THE ITEM, LOTS, POS, AND EACHES ARE ALL IN THE ATTACHED NOTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174279 BD POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4256173 00382903065530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown