BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 23785833 · Received December 11, 2025

    Report

    Report Number
    1911916-2025-00790
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IT WAS REPORTED THAT MOLD APPEARED TO BE PRESENT IN THE 10 ML SALINE FLUSHES. TO SUPPORT THE INVESTIGATION, THIRTY-TWO PREFILLED SYRINGES AND ONE PHOTOGRAPH WERE RECEIVED FOR EVALUATION BY THE QUALITY TEAM. THIRTY SAMPLES ARRIVED IN SEALED FLOW-WRAP PACKAGING, WHILE TWO SAMPLES WERE RECEIVED WITHOUT PACKAGING. A VISUAL INSPECTION WAS CONDUCTED. THE THIRTY SAMPLES IN SEALED PACKAGING SHOWED NO DEFECTS OR IMPERFECTIONS. OF THE TWO SAMPLES WITHOUT PACKAGING, ONE SYRINGE BARREL LUER TIP CONTAINED LUBRICANT FROM THE MOLDING PROCESS, AND THE OTHER SYRINGE EXHIBITED A DAMAGED LUER TIP WITH A DARK-COLORED STAIN THAT WAS NOT EMBEDDED. THE PHOTOGRAPH PROVIDED DEPICTED THE CONDITION OBSERVED IN ONE OF THE RETURNED SAMPLES. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE NOTED. THE SAMPLES WERE SUBSEQUENTLY SENT TO A LABORATORY FOR FURTHER ANALYSIS, WHICH CONFIRMED THAT NO MOLD WAS PRESENT ON THE RETURNED SAMPLES. THE OBSERVED CONDITIONS COULD OCCUR IF A JAM DURING THE MOLDING PROCESS CAUSED DAMAGE AND LEFT EQUIPMENT LUBRICANT ON THE DEVICE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER: 306547, LOT: 5212357. THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE MOLDING PROCESS CONFIRMED PROPER CONVEYOR ALIGNMENT AND SMOOTH PRODUCT FLOW, WITH NO LUBRICANT RESIDUES OBSERVED. THE SAMPLES WERE SHARED WITH ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE CONDITION REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 306547, LOT#: 5212357. RCC RECEIVED A COMPLAINT VIA EMAIL. PIR TEAM CAN WE START INVESTIGATION ON #306547 10ML FLUSH ¿ CUSTOMER CONTACT INFORMATION AND REPORT BELOW: I NEED TO REPORT A PRODUCT QUALITY ISSUE OF THE BD SYRINGE PFILL 10ML FLUSH 9% NACL STERILE, MFG# 306547; SOME NURSING UNITS THAT ARE FINDING WHAT APPEARS TO BE MOLD IN THEIR 10ML SALINE FLUSHES. LOT: 5212357, EXP: 06-30-2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2781335 BD POSIFLUSH SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 5212357 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown