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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 8888119364P
Medical Device Problem Codes Break (1069); Misconnection (1399)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/01/1980
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during use, they suspected a pinhole in the catheter, although they were unable to identify where air was drawn into the system upon patient connection.It was stated that luer lock and slip tip syringes did not fit tightly, although threads look okay.Catheter became infected and was removed.It was also stated that pinhole was previously noted before becoming infected and removed.There was no reported patient outcome.
 
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Brand Name
PALINDROME
Common Device Name
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key8644383
Report Number3009211636-2019-00130
Device Sequence Number254832
Product Code MSD
UDI-Device Identifier10884521157705
UDI-Public10884521157705
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K123196
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number8888119364P
Device Catalogue Number8888119364P
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/06/2019
Initial Report FDA Received Date05/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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