BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9930739 · Received April 6, 2020

    Report

    Report Number
    8041187-2020-00198
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    March 11, 2020
    Report Date
    March 23, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: FOUR PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION, THREE OF THE PHOTOS SHOWS A CANNULA HUB WITH LUER LOCK DAMAGE; THEREFORE, THE INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE INVESTIGATION, THE PROBABLE ROOT CAUSE FOR CANNULA HUB DAMAGE COULD BE DUE TO AN AIR LEAK ON A MAIN CYLINDER IN MANUFACTURING. THE AIR LEAK WOULD HAVE CAUSED INCONSISTENT PICK UP COMPRESSION (HOLDING FORCE) AT THE CANNULA HUB¿S WING, LEADING TO THE CANNULA HUB BECOMING MISALIGNED AND NOT SEATED PROPERLY ON THE TRANSFER PALLET, THEN DAMAGED DURING PICK UP. HOWEVER, THERE IS A 100% AIR LEAKAGE TEST OF THE MANUFACTURING MACHINE THAT WOULD REJECT ANY CANNULA HUB THAT FAILED LEAK TESTING. THE DAMAGED CANNULA HUB WOULD FAIL THE LEAK TEST. HOWEVER, AS THE SAMPLE WAS NOT RETURNED, NO FURTHER INVESTIGATION COULD BE PERFORMED. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT WILL BE REOPENED IF A SAMPLE IS RETURNED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: ABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON PHOTOS RETURNED. ROOT CAUSE DESCRIPTION: THE PROBABLE ROOT CAUSE FOR CANNULA HUB DAMAGE COULD BE DUE TO AIR LEAK ON ZONE 1 PPU MAIN CYLINDER. THE AIR LEAK ON ZONE 1 PPU MAIN CYLINDER WILL CAUSE INCONSISTENT PICK UP COMPRESSION (HOLDING FORCE) AT CANNULA HUB¿S WING, LEADING TO CANNULA HUB MISALIGNMENT AND NOT SEATING PROPERLY ON TRANSFER PALLET, THEN DAMAGED BY ZONE 2 PPU DURING PICK UP. HOWEVER, THERE IS A 100% AIR LEAKAGE TEST IN ZONE 2 OF THE MANUFACTURING MACHINE THAT WOULD REJECT CANNULA HUBS THAT FAIL THE LEAK TEST. THE DAMAGED CANNULA HUB WOULD FAIL THE LEAK TEST. HOWEVER, AS THE SAMPLE WAS NOT RETURNED, NO FURTHER INVESTIGATION COULD BE PERFORMED. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT WILL BE REOPENED WHEN SAMPLE IS RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. THE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT TREND WOULD BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER APPEARED TO BE "MELTED" AND COULDN'T BE ATTACHED TO THE "SWAN-LOCK" DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CANNULA THAT WAS POORLY MANUFACTURED. IT LOOKS AS IF THE PORT HAD MELTED, SO WHEN THE CANNULA WAS IN SITU I COULDN¿T ATTACH A SWAN-LOCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392948 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9241101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other