BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHENA 22GX1.00IN STRAIGHT BC

    MDR report key: 8378719 · Received February 28, 2019

    Report

    Report Number
    8041187-2019-00175
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    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

    H.6. INVESTIGATION: 20 REPRESENTATIVE SAMPLES (UNOPENED) WERE RETURNED FOR INVESTIGATION. 10PCS FROM BATCH 8081043, 5PCS FROM 8116291 AND 5PCS 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 LEAKAGE OCCURRED FROM THE CATHENA 22GX1.00IN STRAIGHT BC'S NON-FUNCTIONING ANTI-REFLUX VALVE AND OUT OF THE HUB AFTER THE REMOVAL OF THE NEEDLE FROM THE PATIENT. AFTERWARD, THE "MULTIGUARD" WAS ALSO REPORTEDLY "NOT WORKING" WHEN ATTEMPTING TO DISCONNECT IT FROM THE NON-FUNCTIONAL ANTI-REFLUX VALVE, CAUSING SALINE USED TO PERFORM A FLUSH TO LEAK AS WELL. LOT # 8116291 WAS REPORTED TO HAVE HAD ONE OCCURRENCE OF THIS EVENT, WHILE LOT #'S 8060126 AND 8183043 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS MDR REPRESENTS 1 OF 10 PATIENTS AFFECTED BY THIS EVENT. AS REPORTED BY THE CUSTOMER, "CATHETER ANTI-REFLUX VALVE DOESN'T FUNCTION AFTER INSERTION OR CONNECTION/DISCONNECTION (MULTIGUARD NOT WORKING). THERE IS BLOOD THAT IS LEAKING PAST THE VALVE AFTER REMOVAL OF THE NEEDLE, AND LEAKING OUT OF THE HUB. INSERTION WAS OBSERVED ON LIVE PATIENT, STEPS FOR INSERTION WERE PERFORMED CORRECTLY, AND AS SOON AS THE NEEDLE WAS PULLED OUT OF THE HUB, THE BLOOD WOULD LEAK UP BY FOLLOWING THE SPRING INSIDE THE CATHETER HUB. CONNECTION WITH A SALINE FLUSH WAS PERFORMED, AFTER DISCONNECTION, CATHETER LEAKED = VALVE NOT FUNCTIONING EITHER. REPEATED THIS TWICE, WITH THE SAME RESULT."

    Additional Manufacturer Narrative · 1

    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. 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 LEAKAGE OCCURRED FROM THE CATHENA 22GX1.00IN STRAIGHT BC'S NON-FUNCTIONING ANTI-REFLUX VALVE AND OUT OF THE HUB AFTER THE REMOVAL OF THE NEEDLE FROM THE PATIENT. AFTERWARD, THE "MULTIGUARD" WAS ALSO REPORTEDLY "NOT WORKING" WHEN ATTEMPTING TO DISCONNECT IT FROM THE NON-FUNCTIONAL ANTI-REFLUX VALVE, CAUSING SALINE USED TO PERFORM A FLUSH TO LEAK AS WELL. LOT # 8116291 WAS REPORTED TO HAVE HAD ONE OCCURRENCE OF THIS EVENT, WHILE LOT #'S 8060126 AND 8183043 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS MDR REPRESENTS 1 OF 10 PATIENTS AFFECTED BY THIS EVENT. AS REPORTED BY THE CUSTOMER, "CATHETER ANTI-REFLUX VALVE DOESN'T FUNCTION AFTER INSERTION OR CONNECTION/DISCONNECTION (MULTIGUARD NOT WORKING). THERE IS BLOOD THAT IS LEAKING PAST THE VALVE AFTER REMOVAL OF THE NEEDLE, AND LEAKING OUT OF THE HUB. INSERTION WAS OBSERVED ON LIVE PATIENT, STEPS FOR INSERTION WERE PERFORMED CORRECTLY, AND AS SOON AS THE NEEDLE WAS PULLED OUT OF THE HUB, THE BLOOD WOULD LEAK UP BY FOLLOWING THE SPRING INSIDE THE CATHETER HUB. CONNECTION WITH A SALINE FLUSH WAS PERFORMED, AFTER DISCONNECTION, CATHETER LEAKED = VALVE NOT FUNCTIONING EITHER. REPEATED THIS TWICE, WITH THE SAME RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170587 CATHENA 22GX1.00IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H.10. 00382903868063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other