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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED
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COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Model Number 8888145045
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the catheter fell out.It was stated that the tissue attenuation into the cuff seemed to be delayed or absent.The catheter was secured with sutures for an extended period of time but in this situation, it was stated that the cuff was clearly exposed.The catheter was inserted and was removed.There was no patient injury.
 
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Brand Name
PALINDROME
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
jacqueline st. pierre
15 hampshire street
mansfield, MA 02048
5084524938
MDR Report Key7582727
MDR Text Key110577644
Report Number3009211636-2018-00168
Device Sequence Number1
Product Code MSD
UDI-Device Identifier10884521017900
UDI-Public10884521017900
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112477
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/09/2017
Device Model Number8888145045
Device Catalogue Number8888145045
Device Lot Number1436400049
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/23/2018
Date Device Manufactured01/08/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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