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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 18GA X 1.16IN INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 18GA X 1.16IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38831214
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 the insyte 18ga x 1. 16in catheter separated from the hub during use and entered and "lodged" into the patient's lung. Intervention was required to remove the broken cannula from the vein, where it was initially thought to be, before it was discovered to have entered into the lung. The following information was provided by the initial reporter, translated from spanish to english: "the catheter separated from the hub and got inside patient's vein. The patient had to have intervention in order to remove the cannula inside the vein. " "the catheter was not extracted from the patient's vein, once it is lodged / locked in the lung. ".
 
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Brand NameINSYTE 18GA X 1.16IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9496397
MDR Text Key186601333
Report Number9610048-2019-00352
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodePA
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,Followup
Report Date 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number38831214
Device Lot Number8255854
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2018
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: 12/19/2019 Patient Sequence Number: 1
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