MAUDE Adverse Event Report: HIGH PRESSURE BRAIDED CONNECTING TUBE

Model Number	G00068
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2015
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 the plastic tube of the high pressure tubing was dissociated with the metal part of the device.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: HIGH PRESSURE BRAIDED CONNECTING TUBE
• MDR Report Key: 7476052
• Report Number: 1820334-2018-01341
• Device Sequence Number: 19218140
• Product Code: DTL
• UDI-Device Identifier: 00827002000681
• UDI-Public: (01)00827002000681(17)170717(10)5137308
• 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: Physician
• 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: G00068
• Device Catalogue Number: HPCT8.8-80-M-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