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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PALIND 28/45 SLOT KIT W/VT; DIALYSIS CATHETER
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COVIDIEN PALIND 28/45 SLOT KIT W/VT; DIALYSIS CATHETER Back to Search Results
Model Number 8888145041
Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2014
Event Type  malfunction  
Event Description
It was reported to covidien on (b)(4) 2014 that a customer had an issue with a dialysis catheter.The customer states that the pt received a palindrome (b)(6) 2014 by (b)(6).There were flow problems since cdk start.State of cdk radiology checked on 2 occasions, tip in the right atrium, which is considered optimal.On (b)(6) 2014, it was very difficult to aspirate and flush the catheter before dialysis treatment.When the catheter was a flushed, a "hissing sound" occurred.There was no leakage at the exit site.A decision was made to replace the catheter with a new one.
 
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
 
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Brand Name
PALIND 28/45 SLOT KIT W/VT
Type of Device
DIALYSIS CATHETER
Manufacturer (Section D)
COVIDIEN
5439 state route 40
argyle NY 12809
Manufacturer (Section G)
COVIDIEN
5439 state route 40
argyle NY 12809
Manufacturer Contact
lawrence rock
15 hampshire street
mansfield, MA 02048
5082616625
MDR Report Key3845465
MDR Text Key4619835
Report Number1317749-2014-00153
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8888145041
Device Catalogue Number8888145041
Device Lot Number303843X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/24/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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