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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 381423
Device Problems Bent (1059); Break (1069); Split (2537); Defective Device (2588)
Patient Problem Abrasion (1689)
Event Date 08/16/2017
Event Type  malfunction  
Event Description
Rn went to start iv for the patient in endoscopy.The angiocath was visually inspected with no obvious signs of defect.As it was placed at the skin to insert, the plastic sheath appeared to split and bent away from the needle and skin.The patient had an approx.1 mm abrasion, but the insertion was stopped as the catheter appeared damaged.The patient was given comfort care and a new device was used successfully.The damaged device was sent to clinical engineering.It was evaluated under a microscope, and some defects were found.
 
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Brand Name
BD INSYTE AUTOGUARD
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
9450 s state street
sandy UT 48070
MDR Report Key6893649
MDR Text Key87350093
Report Number6893649
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 Other
Type of Report Initial
Report Date 09/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2017
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Expiration Date03/31/2020
Device Model Number381423
Device Catalogue Number381423
Device Lot Number7089529
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/20/2017
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer09/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age59 YR
Patient Weight95
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