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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 8888128454P
Medical Device Problem Code Material Puncture/Hole (1504)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, there was a barely visible (tiny) puncture hole found on the underside of the soft lumen of the catheter during dialysis treatment.It was also stated that the nurse saw only small drops of blood on the patient's clothing.The treatment was stopped and a single-lumen dialysis treatment was completed.Clamps were moved above the punctured holes until reinsertion of the guide wire was completed.There was no patient injury.
 
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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 Key8759055
Report Number3009211636-2019-00158
Device Sequence Number19407157
Product Code MSD
UDI-Device Identifier10884521157842
UDI-Public10884521157842
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,health professional,u
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/16/2021
Device Model Number8888128454P
Device Catalogue Number8888128454P
Device Lot Number1635000235
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/17/2019
Initial Report FDA Received Date07/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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