MAUDE Adverse Event Report: COOK IRELAND LTD COLON DECOMPRESSION SET

Catalog Number CDSG-14-175

Device Problem Material Frayed (1262)

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

According to the initial reporter, "the wire guide in the colon decompression kit ¿split¿ and poked the finger of a tech." it was further reported, "guide wire difficult to remove, as tech was pulling on wire it split and stuck him in the finger.Tech was sent to be evaluated and tested for (b)(6) and showed no (b)(6) results or adverse effects.

• Brand Name: COLON DECOMPRESSION SET
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9329033
• MDR Text Key: 166583796
• Report Number: 3005580113-2019-00756
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDSG-14-175
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2019
• Distributor Facility Aware Date: 11/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention