BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 12496902 · Received September 20, 2021

    Report

    Report Number
    9616657-2021-00083
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    July 20, 2021
    Report Date
    September 6, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K141311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1111072. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE NOT AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED ISSUE COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION, THE COMPLAINT IS UNSUBSTANTIATED. THERE WERE NO SAMPLES OR PHOTOS RETURNED. IF A SAMPLE BECOMES AVAILABLE, A FULL INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE EXPERIENCED A DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED DAMAGED ITEM WAS ""UNUSABLE"", THE PLUNGER DOES NOT GO TO THE SYRINGE. THE PACKAGES WERE NOT DAMAGED. WE FOUND DEFECTIVE ONES OF THIS LOT AND DESTROYED THE ENTIRE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395365 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 306546 1111072 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1