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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381523
Device Problems Break (1069); Peeled/Delaminated (1454); Failure to Advance (2524); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)
Patient Problem No Information (3190)
Event Date 08/30/2018
Event Type  malfunction  
Event Description
Multiple events with iv catheters including: during attempt to obtain peripheral iv access, nurse was unable to advance the catheter so pulled it out and the needle was noted to be sticking through the bent catheter. After 2nd attempt, iv access was successfully obtained. (while accessing patient for iv injection, the catheter peeled away from the needle. The 18 gauge jelco attempted to place and needle sheared the catheter in two. These involved the following: the 22 g ref. (b)(4) - lot#8134969, lot # 8120663, & lot # 8095877. The 20 g ref. # (b)(4) - lot#8134963. The 24 g ref. # (b)(4) - lot#7027892.
 
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Brand NameBD INSYTE AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
9450 south state street
sandy UT 84070
MDR Report Key7863713
MDR Text Key119813074
Report Number7863713
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381523
Device Catalogue Number381523
Device Lot Number8134969
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/31/2018
Event Location Hospital
Date Report to Manufacturer09/11/2018
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?
Type of Device Usage

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