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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ IV CANNULA 24 G X 19 MM IV CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ IV CANNULA 24 G X 19 MM IV CATHETER Back to Search Results
Catalog Number 391350
Device Problems Peeled/Delaminated (1454); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2017
Event Type  malfunction  
Manufacturer Narrative
Incorrect awareness date entered on initial mdr. Correction date of 10/02/2017 has been made investigation summary: 1 representative sample was returned for investigation. The sample was subjected to visual inspection. Peelback was not observed on the representative sample. Catheter bevel angle and catheter tip od measurement had performed on the representative sample and the result met the product specification. Catheter curl was observed on the sample in the photo. The actual sample was not returned for further investigation. Thus, no root cause can be determined. Investigation conclusion: catheter curl was observed on the sample in the photo. Root cause description root cause: the actual sample was not returned for further investigation. Thus, no root cause can be determined. Dhr review - no complaint related qn and deviations is raised on the involved batch.
 
Manufacturer Narrative
(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 several bd neoflon¿ iv cannula 24 g x 19 mm had peel back malfunctions during use. One child had to be moved to another hospital due to unsuccessfully starting an infusion catheter on the baby. There was no report of injury or medical intervention.
 
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Brand NameBD NEOFLON¿ IV CANNULA 24 G X 19 MM
Type of DeviceIV 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 Key6984457
MDR Text Key245850328
Report Number8041187-2017-00137
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K011103
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 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2021
Device Catalogue Number391350
Device Lot Number6230408
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 Received10/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2016
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: 10/27/2017 Patient Sequence Number: 1
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