BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 22935520 · Received September 2, 2025

    Report

    Report Number
    1911916-2025-00626
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 27, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION A REPORT WAS RECEIVED INDICATING THE PRESENCE OF A SMALL WORM-LIKE OBJECT WITHIN A FLUSH PACKAGE. TO SUPPORT THE INVESTIGATION, ONE SEALED SAMPLE IN FLOW WRAP PACKAGING AND A CORRESPONDING PHOTOGRAPH WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. UPON INSPECTION OF THE SAMPLE, A FOREIGN OBJECT RESEMBLING AN INSECT WAS OBSERVED INSIDE THE PACKAGING. THE PHOTOGRAPH CONFIRMED THE PRESENCE OF THE ITEM IN QUESTION. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE NOTED. THE SAMPLE WAS FORWARDED TO A LABORATORY FOR FURTHER ANALYSIS. THE RESULTS INDICATED THAT THE CLOSEST MATCH WAS TO HUMAN SKIN; HOWEVER, THE PERCENTAGE OF SIMILARITY WAS LOW, RENDERING THE FINDINGS INCONCLUSIVE. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 306547, LOT 5132413. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR REPORTS ASSOCIATED WITH THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER¿S REPORTED OBSERVATION HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: PRODUCTCOMPLAINT - CUSTOMER CALLED TO REPORT THAT A BUG WAS FOUND IN THE PACKAGE OF A BD POSIFLUSH PREFILLED NORMAL SALINE FLUSH SYRINGE, A LITTLE TINY WORM - REF 306547 LOT 5132413. NOT USED ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248976 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 5132413 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown