BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 23323732 · Received October 17, 2025

    Report

    Report Number
    1911916-2025-00685
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 21, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THERE WERE SALINE FLUSHES STOCKED IN CLEAR PACKAGING WITHOUT WHITE CAPS ON THEM AND SOME PLUNGERS HAD BEEN ENGAGED SO FLUSHES WERE NOT FILLED TO 10ML. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER: 306547 AND LOT NUMBER: 5132413. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY. COMPLAINTS RELATED TO THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE MONITORED AND ANALYZED FOR EMERGING TRENDS BY OUR QUALITY TEAM.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT SALINE FLUSHES WERE STOCKED IN CLEAR PACKAGING WITHOUT WHITE CAPS, AND SOME PLUNGERS HAD BEEN PARTIALLY ENGAGED, RESULTING IN FLUSHES NOT BEING FILLED TO THE FULL 10ML VOLUME. TO SUPPORT THE INVESTIGATION, ONE EMPTY SAMPLE WITHOUT PACKAGING OR FLOW WRAP WAS RECEIVED FOR EVALUATION BY THE QUALITY TEAM. THE PLUNGER ROD AND RUBBER STOPPER WERE FULLY DEPRESSED, AND THE TIP CAP WAS MISSING. THE SYRINGE BARREL LUER LOCK THREADS APPEARED INTACT WITH NO VISIBLE DAMAGE OR IMPERFECTIONS, AND NO ADDITIONAL DEFECTS WERE OBSERVED. THIS CONDITION COULD OCCUR IF A JAM OCCURRED DURING THE TIP CAP ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 306547, LOT 5132413. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE TIP CAP ASSEMBLY PROCESS CONFIRMED THAT SETTINGS WERE CORRECT, AND PRODUCT FLOW WAS CONSISTENT. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND RETURNED SAMPLE ANALYSIS, THE CUSTOMER¿S REPORTED SYMPTOM OF A MISSING TIP CAP HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH FLUSH SYRINGE HAD AN INCORRECT FILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 306547, LOT#: 5132413. RCC RECEIVED A COMPLAINT VIA EMAIL. INJURIES OR ADVERSE EVENT: NO. ITEM: 306547. QUANTITY AFFECTED: 1CS. SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: 10CC 0.9% SODIUM CHLORIDE INJECTION (SALINE FLUSHES) STOCKED IN NICU PAR IN CLEAR PACKAGING WITHOUT WHITE CAPS ON THEM - SOME PLUNGERS HAD BEEN ENGAGED SO FLUSHES WERE NOT FILLED TO 10C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2828714 BD POSIFLUSH SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 5132413 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown