MAUDE Adverse Event Report: COOK INC WAYNE PNEUMOTHORAX TRAY; DQR CANNULA, CATHETER

Catalog Number C-UTPTY-1400-WAYNE-112497

Device Problems Material Frayed (1262); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2015

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

The complainant reported that a patient in the ed (emergency department) needed a chest tube for a pneumothorax, and there was substantial difficulty with the wayne pneumothorax tray.The kits (two lot numbers: this mfr# and related mfr# 1820334-2018-03816) had kinks and frays in the guide wire that made it impossible to thread the chest tube into the chest cavity for pneumothorax drainage.It took 6 attempts to insert a chest tube into the patient, and the patient was awaiting ir for placement of a small chest tube.The physicians all attempted various ways/ workarounds with the only success being placing a pediatric tube for temporary inflation of the patient's lung.After xr (x-ray) confirmation, it was determined that a larger chest tube was necessary.Hence a subsequent attempt and failure.These product problem did not result in any reported serious injuries to the patient.

• Brand Name: WAYNE PNEUMOTHORAX TRAY
• Type of Device: DQR CANNULA, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 8176830
• MDR Text Key: 131143747
• Report Number: 1820334-2018-03815
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 00827002120327
• UDI-Public: (01)00827002120327(17)170330(10)5747374
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2017
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497
• Device Lot Number: 5747374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2015
• 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