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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE PERIPHERAL INSERTED CENTRAL CATHETER (PICC)

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COVIDIEN ARGYLE PERIPHERAL INSERTED CENTRAL CATHETER (PICC) Back to Search Results
Model Number 43304
Device Problems Hole In Material (1293); Leak/Splash (1354); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2017
Event Type  malfunction  
Event Description
Pump alarmed high pressure. Nurse went to flush / aspirate to assess patency and the fluid leaked under the dressing. This was on a pt that needed to go to surgery in the morning and needed to get another picc inserted. When assessing the line afterwards there was a small hole in the part under the dressing but not inserted into the pt.
 
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Brand NameARGYLE PERIPHERAL INSERTED CENTRAL CATHETER (PICC)
Type of DeviceARGYLE PERIPHERAL INSERTED CENTRAL CATHETER (PICC)
Manufacturer (Section D)
COVIDIEN
MDR Report Key7137453
MDR Text Key95506760
Report NumberMW5074137
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 Patient
Type of Report Initial
Report Date 12/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number43304
Device Lot Number1716600236
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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? No
Type of Device Usage

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