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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393222
Device Problem Detachment Of Device Component (1104)
Patient Problems Erythema (1840); Pain (1994); Phlebitis (2004); Swelling (2091); Device Embedded In Tissue or Plaque (3165)
Event Date 07/08/2015
Event Type  Injury  
Manufacturer Narrative
There is no 510(k) for this device as it is manufactured outside the us and not sold in the us. Results: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number for this incident was not provided. Conclusion: without a sample, an absolute root cause for this incident cannot be determined.
 
Event Description
It was reported that a patient had a bd venflon¿ pro safety peripheral safety iv catheter placed in his/her right forearm during a hospital stay. Upon discharge the insertion area was red and swollen and was assessed as thrombophlebitis. After healing, the patient received an ultrasound and it was discovered that 2cm of iv catheter tubing remained in the patient's subcutaneous tissue. The patient had an extra doctor's appointment and also received an x-ray. No further medical intervention was reported as being needed as the patient is pain free and not bothered by the retained broken catheter fragment.
 
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Brand NameBD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key5381539
MDR Text Key36467033
Report Number8041187-2016-00002
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSW
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 01/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number393222
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/20/2016 Patient Sequence Number: 1
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