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

Model Number	8888123435
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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, the catheter¿s venous return was zero and the central line was often blocked.It was stated that consequences for the users are longer hospitalization, treatment longer or postponed (therefore not completed), more catheter handling, increased risk of infection and of venous thrombosis.It was reported that the catheter was patent and working well in the radiology suite, however when the patient showed up for treatment on monday, the catheter was not patent.The patency was checked prior to hooking in the machine and it was not working.The treatment was never started.The procedure was an apheresis and they were unable to retrieve blood.The catheter was not manipulated and dressed using aseptic technique.There was no reported blood loss and the patient was just given a heparin 5000 units (anticoagulant).

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7508635
• Report Number: 3009211636-2018-00145
• Device Sequence Number: 19195754
• Product Code: MSD
• UDI-Device Identifier: 10884521012516
• UDI-Public: 10884521012516
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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 Model Number: 8888123435
• Device Catalogue Number: 8888123435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention