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
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.
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: 7475769
• Report Number: 1820334-2018-01340
• Device Sequence Number: 10802974
• Product Code: DTL
• UDI-Device Identifier: 00827002000650
• UDI-Public: (01)00827002000650(17)170815(10)5215498
• 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