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

Catalog Number PLIP-3.5-18-9-DENNY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

The.018 wires (quantity 2) could not pass thru the peel away sheath during a picc line insertion.It was further noted that the shaft of the dilator was elongated.The procedure was successfully completed with another device of the same rpn.No adverse effects to the patient were reported as a result of this product problem.

• 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: 6930816
• MDR Text Key: 90157290
• Report Number: 1820334-2017-03346
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002115644
• UDI-Public: (01)00827002115644(17)180408(10)5787472
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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-3.5-18-9-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: 04/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1