BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 6421694 · Received March 21, 2017

    Report

    Report Number
    8041187-2017-00023
    Event Type
    Injury
    Date Received
    March 21, 2017
    Date of Event
    February 21, 2017
    Report Date
    March 11, 2017
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. THE SQUARE COVER OF THE SAFETY MECHANISM WAS REMOVED TO OBSERVE FOR ABNORMALITIES. A VISUAL/MICROSCOPIC INSPECTION REVEALED THAT THE "SHARK FIN" PORTION OF THE NEEDLE CAP WAS NOT BETWEEN THE NEEDLE AND THE V-CLIP BEFORE V-CLIP ACTIVATION. A REVIEW OF THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6203411. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: ALTHOUGH THE DHR AND QUALITY NOTIFICATION REVIEW REVEALED NO ABNORMALITIES, IT HAS BEEN DETERMINED THAT THE ROOT CAUSE FOR THIS INCIDENT IS MANUFACTURING RELATED AS THE "SHARK FIN" PORTION OF THE NEEDLE CAP WAS NOT BETWEEN THE NEEDLE AND THE V-CLIP BEFORE V-CLIP ACTIVATION. REMEDIAL ACTION REQUIRED: CAPA (B)(4) HAS BEEN INITIATED FOR THE SAFETY MECHANISM FAILURE THAT LED TO THE NEEDLE STICK INJURY WITH THIS DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER WITH INJECTION VALVE DID NOT RETRACT APPROPRIATELY AFTER USE AND THE USER SUFFERED A CONTAMINATED NEEDLE STICK INJURY TO HIS/HER LEFT INDEX FINGER. BOTH THE SOURCE PATIENT AND USER RECEIVED POST EXPOSURE LAB WORK. THE TEST RESULTS ARE UNKNOWN AND NO FURTHER MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205463 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 6266250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention