BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 16970477 · Received May 20, 2023

    Report

    Report Number
    1911916-2023-00331
    Event Type
    Malfunction
    Date Received
    May 20, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 18, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 3010631. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE FLUSH WAS MISSING CAP ON SYRINGE LUER END, STILL SEALED IN CELLOPHANE WRAPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUSH WAS MISSING CAP ON SYRINGE LUER END, STILL SEALED IN CELLOPHANE WRAPPER." ADDITIONAL INFO RECEIVED ON (B)(6) 2023. THE DATE OF THE FINDING WAS ONE DAY PRIOR TO REPORTING TO BD PRODUCT COMPLAINTS DEPARTMENT, ONLY ONE SYRINGE WAS FOUND AND REPORTED, IT IS UNKNOWN IF OTHER SYRINGES WERE FOUND AND NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016837 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 3010631 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown