BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 22628994 · Received July 28, 2025

    Report

    Report Number
    1911916-2025-00542
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 31, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903065479
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306547 AND LOT NUMBER 5091770. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT SIMILAR ISSUES DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H11 -A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED

    Description of Event or Problem · 0

    IT IS REPORTED, EMPTY FLUSH SYRINGE. EVENT DESCRIPTION: MATERIAL#: 306547. BATCH#: 5091770. EMERGENCY ROOM NURSE REPORTED THAT ONE OF THE SALINE FLUSHES DID NOT CONTAIN ANY SALINE. UPON OPENING THE PACKAGING, THE NURSE ATTEMPTED TO REMOVE THE AIR BUBBLE ONLY TO DISCOVER THAT THERE WAS NO FLUID IN THE SYRINGE. NURSE DISCARDED THE SYRINGE AND GRABBED ANOTHER ONE TO USE, SO NO IMPACT ON PATIENT. POTENTIAL FOR ERROR/HARM IF NURSE HAD PUSHED THE FLUSH INTO IV WITHOUT NOTICING THAT IT WAS ALL AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651311 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 5091770 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown