BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON 2 GN 18GA IV CANNULA

    MDR report key: 12002115 · Received June 15, 2021

    Report

    Report Number
    2243072-2021-01677
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 18, 2021
    Report Date
    July 13, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS OF A VENFLON FROM LOT # 0182274 REGARDING ITEM #391453 WITH THE REPORTED ISSUE OF ¿CATHETER BROKE OFF IN THE VEIN DURING PLACEMENT¿. THE DHR OF PRODUCT NUMBER 391453 AND LOT NUMBER 0.0182274 CHECK FOR ANY QUALITY NOTIFICATION, AND THERE WAS NO QUALITY NOTIFICATION WAS RAISED ON THIS LOT. NO SAMPLES RECEIVED, HOWEVER TWO PHOTOGRAPHS WERE RECEIVED FROM THE CUSTOMER AND WERE USED FOR INVESTIGATION OF THE REPORTED DEFECT. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MATERIAL CODE 0182274 AND LOT NUMBER 0182274 FOR INVESTIGATING THE REPORTED DEFECT. THE TEN RETENTION SAMPLES OF 0.0182274 WERE CHECKED FOR CATHETER DAMAGE. NO RETENTION SAMPLES SHOWED ANY CATHETER DAMAGE ON INVESTIGATION. THE DEFECT COULD NOT BE CONFIRMED. AS PER THE PHOTOGRAPH, THE CATHETER HAS BEEN REINSERTED MANY TIMES DUE TO WHICH THE TIP OF THE PTFE TUBE WAS BROKEN OFF & SLID BACKWARDS. THE PRODUCTION LINE HAS THE CAPABILITY TO ONLINE INSPECT 100% OF THE COMPONENT FOR SUCH A DEFECT. SO IT IS DIFFICULT TO PASS SUCH DEFECT FROM THE PRODUCTION LINE. BASED ON THE PHOTOGRAPHIC EVIDENCE THIS IS RELATED TO PRACTICE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON 2 GN 18GA IV CANNULA CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER BROKE OFF IN THE VEIN DURING PLACEMENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON 2 GN 18GA IV CANNULA CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER BROKE OFF IN THE VEIN DURING PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900082 VENFLON 2 GN 18GA IV CANNULA CATHETER FOZ 0182274

    Patients

    Seq Age Sex Outcome Treatment
    1