MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	8888345611
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2018
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, the hemodialysis catheter was passed on in the patient.After the first session of hemodialysis, it presented inadequate flow.It was necessary to replace the catheter.There was no reported patient 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, at the beginning of the dialysis treatment, the catheter had a lack of blood flow and could not be used due to an occlusion on both arterial and venous lines.The treatment could not even begin because of the lack of flow thus, the treatment was delayed.It was stated that they also tried to reverse the lines and heparin was used as anti-coagulant.The catheter was replaced by another one.There was no reported patient injury.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7659019
• Report Number: 3009211636-2018-00222
• Device Sequence Number: 175992
• Product Code: NIE
• UDI-Device Identifier: 20884521006789
• UDI-Public: 20884521006789
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K020089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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 Date: 04/25/2022
• Device Model Number: 8888345611
• Device Catalogue Number: 8888345611
• Device Lot Number: 1714200089
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR