BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHENA 22GX1.00IN STRAIGHT BC

    MDR report key: 8392429 · Received March 5, 2019

    Report

    Report Number
    8041187-2019-00202
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    00382903868063
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 20 REPRESENTATIVE SAMPLES (UNOPENED) WERE RETURNED FOR INVESTIGATION. 10PCS FROM BATCH 8081043, (B)(4) FROM 8116291 AND (B)(4) 8060126. THE SAMPLES WERE SUBJECTED TO BLOOD ESCAPE TIME (BET) TEST. THE SAMPLES PASSED THE BET TEST, NO LEAKAGE WAS OBSERVED. A REVIEW OF PAST 12 MONTHS QUALITY NOTIFICATION WAS PERFORMED AND NO QUALITY NOTIFICATION WAS RAISED ON THE REPORTED DEFECT OF LEAKAGE. NO ABNORMALITY WAS DETECTED DURING THE PRODUCTION OF THE REPORTED BATCH. THE RETURNED SAMPLE PASSED THE BET TEST. HENCE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THERE WAS A CAPA RAISED FOR BLOOD DROPLET FORMATION AT THE LUER END OF THE CATHETER ADAPTER (REFER TO CAPA#86125). SMALL ID CATHETER TUBING AND SMALL SEPTUM VENTS HAVE BEEN IMPLEMENTED TO ENHANCE THE BLOOD CONTROL FUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE CATHENA 22GX1.00IN STRAIGHT BC EXPERIENCED PRODUCT DAMAGE AND LEAKAGE WITH THE CUSTOMER STATING, "IT WAS REPORTED THE CATHETER ANTI REFLEX VALVE DOES NOT FUNCTION AFTER INSERTION OR CONNECTION/DISCONNECTION AND THERE WAS LEAKING PAST THE VALVE AND OUT OF THE HUB." THIS COMPLAINT IS FOR PATIENT 6 OF 10.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8116291. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2018-04-26. MEDICAL DEVICE LOT #: 8060126. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2018-03-01. MEDICAL DEVICE LOT #: 8183043. MEDICAL DEVICE EXPIRATION DATE: 2021-06-30. DEVICE MANUFACTURE DATE: 2018-07-02.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE CATHENA 22GX1.00IN STRAIGHT BC EXPERIENCED PRODUCT DAMAGE AND LEAKAGE WITH THE CUSTOMER STATING, "IT WAS REPORTED THE CATHETER ANTI REFLEX VALVE DOES NOT FUNCTION AFTER INSERTION OR CONNECTION/DISCONNECTION AND THERE WAS LEAKING PAST THE VALVE AND OUT OF THE HUB." THIS COMPLAINT IS FOR PATIENT 6 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186062 CATHENA 22GX1.00IN STRAIGHT BC SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10 00382903868063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other