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

Catalog Number PLIP-5.5-18-9-DENNY

Device Problems Break (1069); Peeled/Delaminated (1454); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2016

Event Type  malfunction  

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 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
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6930910
• MDR Text Key: 90157476
• Report Number: 1820334-2017-03347
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002115675
• UDI-Public: (01)00827002115675(17)170501(10)4946879
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLIP-5.5-18-9-DENNY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1