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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ IV CANNULA 20 G X 1 IN. INTRAVASCULAR CATHETER

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BECTON DICKINSON BD VENFLON¿ IV CANNULA 20 G X 1 IN. INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391492
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2016
Event Type  Injury  
Manufacturer Narrative
The reported device was manufactured in (b)(6). In this mdr, bd corporate (b)(4) in (b)(6) has been listed. As there is no fda manufacturing site # for (b)(6). 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. A visual inspection showed evidence of a disconnected tube from the catheter. 200 retention samples from the sample lot # were also visually inspected and no abnormalities were found. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 16b2341j. A manufacturing review revealed no discrepancies in machine performance, process/machine disturbance, or stoppages. Conclusion: an absolute root cause for this incident cannot be determined. However, our quality engineer notes that it was confirmed during the investigation that the customer's returned sample was cut by a sharp object which most likely caused the reported incident.
 
Event Description
It was reported that a bd venflon⠉v cannula was used as an arterial line for pressure monitoring in a patient. After opening the catheter dressing, the catheter was found detached from its hub and remained inside the patient's artery. The patient had surgery to remove the broken catheter.
 
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Brand NameBD VENFLON¿ IV CANNULA 20 G X 1 IN.
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key5751400
MDR Text Key48245222
Report Number2243072-2016-00016
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 06/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number391492
Device Lot Number16B2341J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2016 Patient Sequence Number: 1
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