BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR ABG PRESET 1(.6) S/T 23X1 CE

    MDR report key: 8728551 · Received June 24, 2019

    Report

    Report Number
    9617032-2019-00720
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 9, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ARE THE CHANGES: MEDICAL DEVICE TYPE: JKA. PMA / 510(K)#: K022426.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR WHITE POWDER 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-CONFORMANCE'S DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: EVALUATION OF RETURNED SAMPLES DID NOT CONFIRM THE REPORTED DEFECT, AS THE WHITE COTTON ON THE PLUNGER TIP IS A VENTING MECHANISM AND NOT A POWDER. ADDITIONALLY, ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. THIS PRODUCT IS NORMALLY PROVIDED WITH THE WHITE COTTON VENTING MECHANISM IN THE PLUNGER TIP IN THE APPROXIMATE POSITION REQUIRED FOR USE. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A SYR ABG PRESET 1(.6) S/T 23X1 CE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHITE POWDER IN SYRINGE STAMP BLOOD COAGULATED BECAUSE THE HEPARIN IS IN THE SYRINGE STAMP" 100 OCCURRENCES WERE REPORTED AFTER USE, THE DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A SYR ABG PRESET 1(.6) S/T 23X1 CE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHITE POWDER IN SYRINGE STAMP BLOOD COAGULATED BECAUSE THE HEPARIN IS IN THE SYRINGE STAMP" 100 OCCURRENCES WERE REPORTED AFTER USE, THE DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

    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 THAT FOREIGN MATTER OCCURRED WITH A SYR ABG PRESET 1(.6) S/T 23X1 CE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "WHITE POWDER IN SYRINGE STAMP BLOOD COAGULATED BECAUSE THE HEPARIN IS IN THE SYRINGE STAMP". 100 OCCURRENCES WERE REPORTED AFTER USE, THE DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522731 SYR ABG PRESET 1(.6) S/T 23X1 CE SYRINGE JKA BECTON, DICKINSON AND COMPANY (BD) 8262807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other