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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON, & COMPANY INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 382534
Device Problems Component Falling (1105); Crack (1135); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2018
Event Type  malfunction  
Event Description
After inserting the needle, the white release button was pressed and needle retracted into plastic cover. The plastic cover was found cracked at end with piece missing and likely where needle was discharged. Needle flew onto floor with wire coil around it.
 
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Brand NameINSYTE AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON, & COMPANY
9459 south state street
sandy UT 84070
MDR Report Key7537030
MDR Text Key109096803
Report Number7537030
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 Risk Manager
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number382534
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 FDA05/11/2018
Event Location Hospital
Date Report to Manufacturer05/11/2018
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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