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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BD INSYTE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 6133854
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2016
Event Type  malfunction  
Event Description
Attempting iv placement, 3 different catheters sheared. No patient harm. Manufacturer response for iv catheter, insyte (per site reporter): this is a previously reported issue that is reoccurring.
 
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Brand NameINSYTE
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
5859 farinon dr. ste 200
san antonio TX 78249
MDR Report Key6124400
MDR Text Key60776183
Report Number6124400
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2016
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Lot Number6133854
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/18/2016
Event Location Hospital
Date Report to Manufacturer10/18/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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