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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 393224
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2018
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone: (b)(6). 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 once the bd venflon¿ pro safety peripheral safety iv catheter had venous return at the valve level and there is a risk for exposure to blood. Found during use. No reports of blood exposure, serious injury or medical intervention noted.
 
Manufacturer Narrative
Investigation summary: three representative samples were returned for investigation of this complaint. The three representative samples were subjected to visual inspection of cannula hub, injection valve test, and catheter adapter leak test. All three representative samples passed the acceptance criteria. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7357452. Investigation conclusion: the non-conformance of this complaint could not be determined as all the representative samples passed the acceptance criteria.
 
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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
MDR Report Key7374155
MDR Text Key103679294
Report Number8041187-2018-00073
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2020
Device Catalogue Number393224
Device Lot Number7357452
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/27/2018 Patient Sequence Number: 1
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