BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 6398204 · Received March 12, 2017

    Report

    Report Number
    8041187-2017-00026
    Event Type
    Malfunction
    Date Received
    March 12, 2017
    Date of Event
    February 21, 2017
    Report Date
    April 27, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Removal / Correction Number
    82497
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RESULTS: THE CUSTOMER HAS INDICATED THAT SAMPLES ARE AVAILABLE FOR EVALUATION. HOWEVER, PRIOR TO RECEIVING SAMPLES THE MANUFACTURING SITE IN (B)(4) COMPLETED A NO SAMPLE INVESTIGATION. AS PART OF THE INVESTIGATION, A REVIEW OF THE DEVICE HISTORY RECORD 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: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. IN THE EVENT THAT SAMPLES ARE RECEIVED, A NEW INVESTIGATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: TWO USED SAMPLES WERE RETURNED FOR EVALUATION. SAMPLE 1: A VISUAL INSPECTION REVEALED THAT THE TETHER WAS DETACHED FROM THE NEEDLE HUB. A MICROSCOPIC INSPECTION REVEALED THAT THE HEAT STAKE POST HAD NO DAMAGE AND MEASURED WITHIN SPECIFICATION OF 3.5-4MM. THE TETHER WAS OBSERVED TO BE DEFORMED ON THE EDGES. THE DEFORMITY WAS LIKELY CAUSED BY STRETCHING. SAMPLE 2: A VISUAL INSPECTION REVEALED THAT THE NEEDLE TIP WAS NOT COVERED BY THE SAFETY MECHANISM. A MICROSCOPIC INSPECTION REVEALED NO DAMAGE TO THE V-CLIP. THE CATHETER HUB OF THIS DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD 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 RETURNED SAMPLES EXHIBITED DEFECTS, BASED ON THE DEVICE HISTORY RECORD AND MANUFACTURING REVIEWS, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. REMEDIAL ACTION REQUIRED: ALTHOUGH A ROOT CAUSE COULD NOT BE DETERMINED, CAPA (B)(4) HAS BEEN INITIATED TO INVESTIGATE NEEDLE STICK INJURY RELATED TO THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM OF A 22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER WITH INJECTION VALVE FAILED TO FUNCTION PROPERLY DURING A TEST IN A CLINICAL TRAINING DEPARTMENT AND THE USER SUFFERED A NEEDLE STICK INJURY. THE NEEDLE DID NOT COME IN CONTACT WITH A PATIENT, THEREFORE THE INJURY WAS FROM A CLEAN NEEDLE. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180537 22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 6203411

    Patients

    Seq Age Sex Outcome Treatment
    1 Other