BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ PRO SAFETY IV CATHETER 20G

    MDR report key: 5495042 · Received March 11, 2016

    Report

    Report Number
    8041187-2016-00017
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    February 12, 2016
    Report Date
    March 22, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DEVICE USED IN THIS INCIDENT IS UNKNOWN. TWO POTENTIAL LOT NUMBER HAVE BEEN PROVIDED FOR THE REPORTED CATALOG NUMBER. LOT 5265426 MEDICAL DEVICE EXPIRATION DATE: 9/30/2018 DEVICE MANUFACTURE DATE 9/22/2015. LOT 5030237 MEDICAL DEVICE EXPIRATION DATE: 1/31/2018 DEVICE MANUFACTURE DATE 1/30/2015. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US.

    Additional Manufacturer Narrative · 1

    RESULT - TWELVE (B)(4) SAMPLES WERE RECEIVED FOR EVALUATION ON MARCH 15, 2016, INCLUDING 6 ACTUAL AND 6 REPRESENTATIVE SAMPLES. THE 6 REPRESENTATIVE (SEALED) SAMPLES WERE VISUALLY INSPECTED AND NOTED THAT THE PACKAGES ARE FULLY SEALED WITH NO SEAL DAMAGE. BASED ON THE EVALUATION, THE SAMPLES RECEIVED DID NOT OBSERVE ANY VISUAL DEFECT. THE 6 ACTUAL (CONTAMINATED) SAMPLES HAVE BEEN USED HENCE BD IS UNABLE TO FURTHER INVESTIGATE. LOT 5265426 WAS PRODUCED IN OCTOBER 2015. LOT 5030237 WAS PRODUCED IN FEBRUARY 2015. NO SIMILAR COMPLAINT HAS BEEN RECEIVED ON THE LOT NUMBERS REPORTED IN THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY REVEALED NO ABNORMALITIES OR QUALITY NOTIFICATIONS DURING PRODUCTION OF THE REPORTED LOT NUMBERS. NO ABNORMALITY WAS REPORTED IN THE CERTIFICATE OF IRRADIATION AND LAL FOR THE COMPLAINT LOTS. THE PREVENTIVE MAINTENANCE, CALIBRATION, AND EQUIPMENT WERE REVIEWED AND NO ABNORMALITY WAS OBSERVED THAT COULD HAVE INFLUENCED THE ISSUE. CONCLUSION - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. BASED ON THE EVALUATION, THE REPRESENTATIVE (SEALED) SAMPLES RECEIVED WERE VISUALLY INSPECTED AND THE PACKAGES WERE FULLY SEALED WITH NO SEAL DAMAGE. BASED ON THE EVALUATION, THE SAMPLES RECEIVED DID NOT OBSERVE ANY VISUAL DEFECT. THE ACTUAL (CONTAMINATED) SAMPLES HAD BEEN USED HENCE BD WAS UNABLE TO FURTHER INVESTIGATE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT (B)(6), THE PATIENT WAS TREATED WITH UNACID (SULTAMICILLIN) FOLLOWING PHLEBITIS FROM THE SUSPECT DEVICE. ALTHOUGH IT IS UNKNOWN WHO PLACED AND OPERATED THE DEVICE, IT WAS REPORTED THAT THE RESCUE SERVICE AT THE FACILITY PLACES 50% OF THE VASCULAR ACCESS DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150858 BD VENFLON¿ PRO SAFETY IV CATHETER 20G INTRAVENEOUS CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention