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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 8888128455
Medical Device Problem Code Material Puncture/Hole (1504)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/27/2018
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, during use, tiny puncture holes were noted in the soft extension lumen of the catheter just proximal to the clamps.This was discovered during dialysis when the nurse saw only small drops of blood on the patient's clothing.The dialysis was stopped.Clamps were moved above the puncture holes until urgent reinsertion was completed.Reinsertion was successful and 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 Key8759033
Report Number3009211636-2019-00157
Device Sequence Number1342207
Product Code MSD
UDI-Device Identifier10884521013025
UDI-Public10884521013025
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K112477
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 Date12/09/2017
Device Model Number8888128455
Device Catalogue Number8888128455
Device Lot Number1436400050
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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