MAUDE Adverse Event Report: COOK INC ULTRATHANE RING-MCLEAN COOK-COPE TYPE LOCKING LOOP SUMP DRAINAGE SET; GCB NEEDLE, CATHETER

Catalog Number	RMSU-12-18-ACL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2015
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.
Event or Problem Description
It was reported that in two of the ultrathane ring-mclean cook-cope type locking loop sump drainage sets, the wires became stuck and broken within the drain during an abscess drainage procedure.No injuries or additional procedures were reported, and no pieces of the wires were left in the patient.

• Brand Name: ULTRATHANE RING-MCLEAN COOK-COPE TYPE LOCKING LOOP SUMP DRAINAGE SET
• Common Device Name: GCB NEEDLE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7784812
• Report Number: 1820334-2018-02523
• Device Sequence Number: 1188376
• Product Code: GCB
• UDI-Device Identifier: 00827002077683
• UDI-Public: (01)00827002077683(17)171009(10)5298694
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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 Expiration Date: 10/23/2014
• Device Catalogue Number: RMSU-12-18-ACL
• Device Lot Number: 5298694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1