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

Model Number	8888102004HP
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
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 treatment for crrt (continuous renal replacement therapy), line was placed without incident, and was confirmed with us (ultrasound), as per the resident performing the procedure, there was no resistance to inserting the wire.However, when they tried to remove the wire, they are unable to remove it.It was stated that the guide wire that came with the kit was used.They called a vascular surgeon for assistance who was ultimately able to remove the wire which was kinked.The guide wire and catheter was removed as one piece after they tried to manipulate the catheter and guide wire, the wire came out intact and it was stated that it was a femoral line.No tools was used to remove the wire, but was stated that some force was needed but no excessive.It was stated that the wire was too flimsy to place in a line, especially on a dialysis line which required multiple dilations.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: 8604574
• Report Number: 3009211636-2019-00121
• Device Sequence Number: 14081050
• Product Code: NIE
• UDI-Device Identifier: 10884521128002
• UDI-Public: 10884521128002
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 8888102004HP
• Device Catalogue Number: 8888102004HP
• Device Lot Number: 1814300160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 62