BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD A-LINE¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 7130864 · Received December 19, 2017

    Report

    Report Number
    9617032-2017-00636
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 28, 2017
    Report Date
    January 19, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMF
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURING: CHANGED/CORRECTED FROM 12/01/2107 TO 12/01/2017.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOTTING AND LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR CLOTTING AND LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). 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 · 1

    IT WAS REPORTED DURING USE OF THE BD A-LINE¿ ARTERIAL BLOOD COLLECTION SYRINGE THE CLIENT REPORTS HAVING PROBLEMS WITH THE SYRINGES OF GASES, THE PLUNGER AND THE INNER PART OF THE SYRINGE IS VERY LOOSE, THE BLACK OBTURATOR IS ALSO CAUSING THE BLOOD TO BE SPILLED AT THE END AND RENDERING THE SAMPLES UNUSABLE. THEY ALSO REFER TO COAGULATED SAMPLES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910533 BD A-LINE¿ ARTERIAL BLOOD COLLECTION SYRINGE SYRINGE WITH NEEDLE FMF BECTON, DICKINSON AND COMPANY (BD) 7111783

    Patients

    Seq Age Sex Outcome Treatment
    1 Other