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

Model Number	8888101002HP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2018
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 luer adapter was detached.It was reported that the third port adapter broke loose from tubing when the nurse tried to remove the iv (intravenous) line from it.It was also indicated that the nurse was having trouble, trying to disconnect the iv tubing from the pigtail hub on the dialysis triple lumen port.After a couple of seconds of wiggling the iv tubing in attempts to get free, the pigtail hub broke off from the tubing, and new triple lumen dialysis catheter was placed after removal.It was reported there was no 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: 7798694
• Report Number: 3009211636-2018-00283
• Device Sequence Number: 1536290
• Product Code: NIE
• UDI-Device Identifier: 10884521127968
• UDI-Public: 10884521127968
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K102605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2018

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: 8888101002HP
• Device Catalogue Number: 8888101002HP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 137