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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER Back to Search Results
Catalog Number 393226
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/16/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. (b)(6). Investigation summary: 2 photos were returned for investigation. Investigation conclusion: 2 photos were returned for investigation. The 1st returned photo shows 1 used cannula hub with catheter broken. The 2nd photo shows 1 broken catheter inside bottle. Able to confirm the customer experience based on the returned photos. No capa raised at this point as no sample was returned for investigation. Root cause description: however, as the actual sample was not returned and defect could not be seen clearly from the photos returned, a review of the past 12 months qn was performed. No qn related to reported defect was raised. Complaint will be reopened when sample is returned. Rationale: the root cause cannot be determined. Complaint trend would be monitored.
 
Event Description
It was reported that bd venflon¿ pro safety shielded iv catheter separated from the hub. This was discovered during use. The following information was provided by the initial reporter: when the venflon (cubital vein, left) was removed, the small tube loosened at the end of the medical device and remained in the vein. This had to be surgically removed.
 
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Brand NameBD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
Type of DeviceCATHETER
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
8015652341
MDR Report Key9549112
MDR Text Key173688092
Report Number8041187-2019-01069
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAU
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 Other Health Care Professional
Type of Report Initial
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2022
Device Catalogue Number393226
Device Lot Number9241529
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 Received12/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2019
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: 01/03/2020 Patient Sequence Number: 1
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