MAUDE Adverse Event Report: COOK INC COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

Model Number	G35082
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/20/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name: mpb catheter, hemodialysis, non-implanted.Product code: mpb.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that the cook turbo-flo hd hemodialysis catheter was successfully placed, but the physician experienced difficulty when attempting to remove the wire.The physician had to use force when removing the wire which resulted in untangling of the wire.The catheter was removed and another puncture of the subclavian vein was required to insert a new vascular catheter.No sections of the device remained inside of the patient's body as a result of the product problem, and there was no other patient impact reported.

• Brand Name: COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7523792
• Report Number: 1820334-2018-01481
• Device Sequence Number: 13866215
• Product Code: MPB
• UDI-Device Identifier: 00827002350823
• UDI-Public: (01)00827002350823(17)160811(10)5197948
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Report Date (Section B): 05/17/2018

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 Model Number: G35082
• Device Catalogue Number: C-HDCS-1201J
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 97