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

Model Number	8888345629
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	07/05/2018
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, there was an obstruction of flow caused by a twist of the catheter that has a more flexible and soft material.This torsion caused permanent crease without improvement with correct positioning of the catheter.It was stated that there was an increase in cases due to this mechanical problem of the catheter.For this reason, patients experienced more frequent catheter changes as well as increased catheter manipulation and increased risk of infection.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7737276
• Report Number: 3009211636-2018-00259
• Device Sequence Number: 11042392
• Product Code: NIE
• UDI-Device Identifier: 20884521006796
• UDI-Public: 20884521006796
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 08/09/2021
• Device Model Number: 8888345629
• Device Catalogue Number: 8888345629
• Device Lot Number: 1625300122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1