MAUDE Adverse Event Report: COOK INC THAL-QUICK ABSCESS DRAINAGE SET; GBX CATHETER, IRRIGATION

Catalog Number	TQAS-1600-J
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2016
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
It was reported that the dilator of the thal-quick abscess drainage set became stuck in the drainage catheter.This device was removed, and the procedure was completed with another set.There were no injuries or additional procedures.The device was returned and examined, revealing that it was actually the dilator with the guidewire lodged inside of it, along with an unidentified hardened foreign matter.It was also found that the safety wire was broken, and the coils were elongated.

• Brand Name: THAL-QUICK ABSCESS DRAINAGE SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7377082
• Report Number: 1820334-2018-00877
• Device Sequence Number: 18864041
• Product Code: GBX
• UDI-Device Identifier: 00827002063396
• UDI-Public: (01)00827002063396(17)181030(10)6311003
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 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: TQAS-1600-J
• 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