MAUDE Adverse Event Report: COOK INC COOK ACCESS PLUS LUER-LOCK HIGH-VOLUME INFUSION INTRODUCER SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the complaint history, drawings, functional testing, device history record, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.Visual inspection of the cook access plus luer-lock high-volume infusion introducer set destructively tested by the end user was conducted.This sheath assembly was returned in an unused and damaged condition.Inspection of the sheath found that the hub was separated from the sheath.The flare of the sheath tubing was slightly distorted and off center.The through hole of the connector cap was measured with pin gauges and within specifications.Unopened and unused devices were also returned for evaluation including 3 devices from the lot that is the subject of this report.Five additional devices from a different lot were also received.All devices were tensile strength tested to failure and the results exceeded the minimum tensile strength requirements.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, evaluation of the returned devices and the results of our investigation, no product failure was identified.A root cause for the customers testing experience could not be determined.We will continue to monitor for similar complaints.Initial parent (b)(4).
Event or Problem Description
International customer reported that the hub of the cook access plus luer-lock high-volume infusion introducer set separated while conducting in-house testing of the device following a previously reported hub separation.The forces applied and testing parameters utilized by the end user were not provided.The device was not intended for patient use at the time of testing, accordingly, there is no patient involvement.The destructively tested device and unused samples were returned for evaluation.No further event details were provided.

• Brand Name: COOK ACCESS PLUS LUER-LOCK HIGH-VOLUME INFUSION INTRODUCER SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6456904
• Report Number: 1820334-2017-00575
• Device Sequence Number: 563148
• Product Code: DYB
• UDI-Device Identifier: 00827002074040
• UDI-Public: (01)00827002074040(17)181215(10)6457052
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 04/04/2017

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: N/A
• Device Catalogue Number: C-FSSI-9.0-35-J-10.5
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1