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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL (SINGAPORE) UNSPECIFIED VENFLON PRO¿ SAFETY IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Entrapment of Device (1212); Device Or Device Fragments Location Unknown (2590)
Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)
Event Date 01/16/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that in (b)(6) 2017 a patient had an unspecified bd venflon pro¿ safety iv catheter removed without issue but was complaining of pain. The patient went home but a few days later was still complaining of pain and went back to see the doctor. The patient was sent for an ultrasound and it was confirmed that a 1-2mm of catheter remained in the patient¿s vessel. The patient was then scheduled to have surgery for removal but when re-scanned the catheter was no longer visible.
 
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Brand NameUNSPECIFIED VENFLON PRO¿ 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 Key7253054
MDR Text Key99548274
Report Number8041187-2018-00042
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
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 Received01/16/2018
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 Initial

Patient Treatment Data
Date Received: 02/08/2018 Patient Sequence Number: 1
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