BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRE-FILLED NORMAL SALINE SYRINGE

    MDR report key: 12694147 · Received October 25, 2021

    Report

    Report Number
    1911916-2021-01105
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306593 AND LOT NUMBER 0231937. 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. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD¿ PRE-FILLED NORMAL SALINE SYRINGE THERE WAS A DAMAGED/DEFORMED PRODUCT - DEVICE IS OPERABLE.. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN USING THE FLUSH, THE BARREL OF THE FLUSH WAS FOUND TO BE CRACKED. REPLACED WITH A NEW ONE TO COMPLETE THE TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587088 BD PRE-FILLED NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0231937

    Patients

    Seq Age Sex Outcome Treatment
    1