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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AUTOGUARD BC WINGED CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC SHORT-TERM LESS THAN 30 DAYS

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BECTON DICKINSON AUTOGUARD BC WINGED CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 8114638
Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem Discomfort (2330)
Event Date 09/13/2018
Event Type  malfunction  
Event Description
Nurse was pre-opting a pt. Upon piercing the pt's skin to start an i. V. , the pt began to bleed around the catheter. Nurse did not advance the catheter further, and ended up pulling the catheter out. Upon inspection, the nurse noted that the catheter tip was bent. Another nurse who was assisting inspected the catheter as well and noticed a piece of the catheter tip was broken off. Pt was complaining of discomfort to the site but the bleeding stopped. Anesthesia entered the room and was informed of the situation. Anesthesia ordered a hand and chest xray of the pt, which confirmed no trace of the missing catheter piece. Frequency: 4 times a day, route: intravenous. Therapy start date: (b)(6) 2018, therapy end date: (b)(6) 2018. Reason for use: to start an i. V.
 
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Brand NameAUTOGUARD BC WINGED CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key7905893
MDR Text Key121857586
Report NumberMW5080088
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Lot Number8114638
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/24/2018 Patient Sequence Number: 1
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