MAUDE Adverse Event Report: COOK INC PEEL-AWAY DENNY SHEATH INTRODUCER SET; DYB INTRODUCER, CATHETER

Catalog Number	PLIP-5.5-18-9-DENNY
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Upon opening the package in the beginning of the surgery, the nurse discovered the abnormal peel off between the top and the tube.It was further noted that the sheath had separated from the tabs and the sheath material that was attached to the pull tabs had signs of the material being sliced.There was no harm to the patient as the device did not make patient contact.The device was immediately switched with another brand's introducer.

• Brand Name: PEEL-AWAY DENNY SHEATH INTRODUCER SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6930910
• Report Number: 1820334-2017-03347
• Device Sequence Number: 1112000
• Product Code: DYB
• UDI-Device Identifier: 00827002115675
• UDI-Public: (01)00827002115675(17)170501(10)4946879
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2017

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 Catalogue Number: PLIP-5.5-18-9-DENNY
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/09/2017
• Patient Sequence Number: 1