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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY IV CATHETER 20G INTRAVENEOUS CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY IV CATHETER 20G INTRAVENEOUS CATHETER Back to Search Results
Catalog Number 393264
Device Problem Insufficient Information (3190)
Patient Problem Phlebitis (2004)
Event Date 02/12/2016
Event Type  Injury  
Manufacturer Narrative
The exact device used in this incident is unknown. Two potential lot number have been provided for the reported catalog number. Lot 5265426 medical device expiration date: 9/30/2018 device manufacture date 9/22/2015. Lot 5030237 medical device expiration date: 1/31/2018 device manufacture date 1/30/2015. There is no 510(k) for this device as it is manufactured outside the us and not sold in the us.
 
Event Description
It was reported that at (b)(6), the patient was treated with unacid (sultamicillin) following phlebitis from the suspect device. Although it is unknown who placed and operated the device, it was reported that the rescue service at the facility places 50% of the vascular access devices.
 
Manufacturer Narrative
Result - twelve (b)(4) samples were received for evaluation on march 15, 2016, including 6 actual and 6 representative samples. The 6 representative (sealed) samples were visually inspected and noted that the packages are fully sealed with no seal damage. Based on the evaluation, the samples received did not observe any visual defect. The 6 actual (contaminated) samples have been used hence bd is unable to further investigate. Lot 5265426 was produced in october 2015. Lot 5030237 was produced in february 2015. No similar complaint has been received on the lot numbers reported in this incident. A review of the device history revealed no abnormalities or quality notifications during production of the reported lot numbers. No abnormality was reported in the certificate of irradiation and lal for the complaint lots. The preventive maintenance, calibration, and equipment were reviewed and no abnormality was observed that could have influenced the issue. Conclusion - bd was not able to duplicate or confirm the customer¿s indicated failure mode. Based on the evaluation, the representative (sealed) samples received were visually inspected and the packages were fully sealed with no seal damage. Based on the evaluation, the samples received did not observe any visual defect. The actual (contaminated) samples had been used hence bd was unable to further investigate. An absolute root cause for this incident cannot be determined.
 
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Brand NameBD VENFLON¿ PRO SAFETY IV CATHETER 20G
Type of DeviceINTRAVENEOUS 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 Key5495042
MDR Text Key40157179
Report Number8041187-2016-00017
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
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 03/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number393264
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2016
Was Device Evaluated by Manufacturer? Yes
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: 03/11/2016 Patient Sequence Number: 1
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