MAUDE Adverse Event Report: COOK INC DRAINAGE BAG CONNECTOR CONNECTING TUBE

Catalog Number	CTU14.0-30-ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code: gcd.(b)(4).Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported four drainage bag connector connecting tubes were ordered but not received.This meant the patient scheduled to have two chest tubes placed on (b)(6) 2018 had to reschedule or go to another facility.This incident is reported as an adverse event as patient care was allegedly postponed.
Additional Manufacturer Narrative
Corrected data: upon further review, this event does not represent an mdr reportable event as it does not match the definition of a complaint provided in 21cfr 820.3(b).The facility received the device on (b)(6) 2018, 5 days prior to the procedure.

• Brand Name: DRAINAGE BAG CONNECTOR CONNECTING TUBE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7529379
• Report Number: 1820334-2018-01522
• Device Sequence Number: 19230105
• Product Code: GCD
• UDI-Device Identifier: 00827002022782
• UDI-Public: (01)00827002022782(17)210312(10)8658664
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: CTU14.0-30-ST
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention