MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE TRAY; GBX CATHETER, IRRIGATION

Catalog Number	C-PPDY-850-IMH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2015
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.Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
Event or Problem Description
The complainant reported that a pleural drainage procedure was performed and the wire guide began to unravel as the doctor was removing it.This unraveling started about 3 inches from the j-tip end and this part was in the patient when this occurred.The doctor was able to remove the entire wire from the patient and no section of the wire detached inside the patient.There were no reported adverse effects to the patient as a result of the product problem.

• Brand Name: FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE TRAY
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7376973
• Report Number: 1820334-2018-00891
• Device Sequence Number: 1144059
• Product Code: GBX
• UDI-Device Identifier: 00827002557246
• UDI-Public: (01)00827002557246(17)160301(10)4592378
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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 Catalogue Number: C-PPDY-850-IMH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1