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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393224
Device Problems Fluid Leak (1250); Hole In Material (1293)
Patient Problem No Information (3190)
Event Date 09/05/2017
Event Type  Injury  
Manufacturer Narrative
127 representative samples received. All 127 samples were subjected to visual inspection of the catheter tube and catheter adapter leak test. All the 127 samples pass the visual inspection of the catheter tube. No hole was observed on the catheter. Catheter of the representative sample. All the 127 samples pass the catheter adapter leak test the non-conformance of this complaint could not be determined. Complaint trend will be monitored. Dhr was reviewed. No qn issued for this vps batch. Manufacturing review: no abnormalities observed after reviewing preventive maintenance, calibration and equipment.
 
Manufacturer Narrative
Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that there was a hole in the ¿plastic cannula¿ of the 20 g x. 32 mm bd venflon¿ pro safety peripheral safety iv catheter, which allowed blood leakage and patients treatment plan to change. Additional attempts to place an iv line were unsuccessful. Patient¿s course of treatment was changed and the patient received a non-contrast ct (vs the originally planned ct with contrast).
 
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Brand Name20 G X .32 MM BD 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 Key6898989
MDR Text Key253470951
Report Number8041187-2017-00106
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,health professional,o
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2020
Device Catalogue Number393224
Device Lot Number7110267
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2017
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: 09/27/2017 Patient Sequence Number: 1
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