MAUDE Adverse Event Report: COOK INC HIGH PRESSURE BRAIDED CONNECTING TUBE

Model Number	G00065
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field for could not be populated due to a technical limitation.Common name: dtl adaptor, stopcock, manifold, fitting, cardiopulmonary bypass product code: dtl.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.Blank fields on this form indicate the information is unknown or unavailable.
Event or Problem Description
It was reported that prior to patient contact, a technician connected the high pressure braided connecting tube to the power injector and it was found to be leaking.Another device was used to successfully complete the procedure.

• Brand Name: HIGH PRESSURE BRAIDED CONNECTING TUBE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7475215
• Report Number: 1820334-2018-01339
• Device Sequence Number: 16530118
• Product Code: DTL
• UDI-Device Identifier: 00827002000650
• UDI-Public: (01)00827002000650(17)170601(10)5023398
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 05/01/2018

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: G00065
• Device Catalogue Number: HPCT8.8-30-P-FM
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 48