MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Catalog Number ULT12.0-38-25-P-6S-CLM-RH

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 01/06/2016

Event Type  malfunction  

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 Description

A chest tube was inserted on (b)(6) 2016.The next day, the nursing staff found that the chest tube had come apart at the connection between the ultrathane tube and mac-loc hub.The tube remained in the body, but the mac-loc plastic piece fell completely off.The patient was not highly mobile, so it is unlikely that they could have tugged or pulled at the tube.The drainage connector was properly and adequately secured and remained in the patient.The chest tube catheter was attached to a pleurevac gravity drainage.The ultrathane tube remains inside patients body, clamped.Patient will be assessed and tube will either be removed or replaced.Repeat chest imaging and possible tube replacement.It is unkown whether the chest tube required replacement.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6786153
• MDR Text Key: 82659425
• Report Number: 1820334-2017-02427
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/10/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: ULT12.0-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 100 YR