MAUDE Adverse Event Report: COOK INCORPORATED WAYNE; CATHETER AND TIP, SUCTION

Model Number	G56537
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Placement of pigtail at bedside, obturator stopcock allows for connection to suction, no equipment "hard stop" that stylet/obturator attached to suction and not removed.

• Brand Name: WAYNE
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 13093104
• Report Number: 13093104
• Device Sequence Number: 4156490
• Product Code: JOL
• UDI-Device Identifier: 00827002565371
• UDI-Public: (01)00827002565371
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2021
• Report Date (Section F): 12/14/2021

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 Model Number: G56537
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497-IMH
• Device Lot Number: 14088613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/14/2021