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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 22GA X 1.0IN INTERVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 22GA X 1.0IN INTERVASCULAR CATHETER Back to Search Results
Catalog Number 38831214
Device Problem Leak/Splash (1354)
Patient Problems Perforation of Vessels (2135); Rupture (2208)
Event Date 09/02/2019
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. 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 a needle through the catheter occurred during use with a insyte 22ga x 1. 0in. The following information was provided by the initial reporter, "catheter rigid and complicates its use in children with difficult access, the insertion into the vein seems to adhere, which causes the blood vessel to rupture and thus venous access is lost. In addition, there has been rupture of the cannula once installed, fracturing. And on another occasion the needle of the cannum pierces the teflon, breaking the blood vessel at the time of its installation. It has been repeated several times with different nurses. " 5 occurrences were reported. 1 of 3 complaints.
 
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Brand NameINSYTE 22GA X 1.0IN
Type of DeviceINTERVASCULAR 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 Key9119646
MDR Text Key202720978
Report Number9610048-2019-00295
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCI
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 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number38831214
Device Lot NumberUNKNOWN
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 Received09/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/25/2019 Patient Sequence Number: 1
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