MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EASY TUBE, 41R; TRACHEOSTOMY TUBE

Catalog Number 180041

Device Problem Air Leak (1008)

Patient Problem Death (1802)

Event Date 07/22/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).A hospital representative acknowledged that the patient died, but declared that it was not the tube (device) that caused the patient's death.The user facility reports that the patient's condition was very bad with serious underlying diseases when the patient was admitted to the emergency department of the hospital.Evaluation codes (cont.) method; conclusion(s) - conclusion code could not be chosen.The complaint was confirmed, but the root cause is unknown.; the customer returned one rusch 41 fr easy tube for investigation.The et tube was visually examined with and without magnification.Visual examination of the et tube revealed that the et tube appears used.The green cuff appears to have detached from extruded tube at the machine end.Adhesive can be seen where the green cuff has detached along the tubing as well as on the rim of the cuff itself.The cuff is detached all the way around the tube.The patient end of the cuff remains attached and adhesive can be seen applied on the cuff and tubing.The returned et tube was functionally tested by attempting to inflate both the clear cuff and green balloon.Both the pilot balloon and cuff inflated.Other remarks: the et tube was submerged under water and no leaks could be seen exiting the clear cuff or the pilot balloon.The green cuff was inflated following the same process.The green cuff deflated immediately upon injection of air.Neither the pilot balloon, nor the green cuff would inflate.The et tube was again submerged underwater and an air leak can be seen surrounding the green cuff at the machine end.The green cuff is completely detached at the machine end.The device history record investigation did not show issues related to complaint.A corrective action is not required at this time as the potential cause of detached green cuff could not be determined based upon the information provided & the sample received.The green cuff was determined to be completely detached at the machine end which resulted in an air leak.All et tubes are 100% inspected for inflation and deflation at manufacturing by inflating the cuffs and allowing them to remain inflated for four hours prior to being deflated.It cannot be determined at what point the green cuff detached from the extruded tube as the defect was discovered during use.This complaint will be further investigated under nc (b)(4).The reported complaint of the balloon leaking during use on the patient was confirmed based on the sample received.A potential root cause could not be determined.

Event Description

The customer alleges that the device had an air leak from the balloon.

Manufacturer Narrative

(b)(4).Corrected data: additional information was received by the customer and it was revealed that the sample that was sent in previously and investigated was not the actual sample that was involved in the reported complaint.The customer accidentally sent in the wrong device.The actual device was not available for investigation; however, the customer did send in a photo of the actual device.A visual exam was performed on the photo received and it was observed that the tube was used as biological material could be seen on the cuff.It was also observed that there was a hole in the green cuff.No other defects were found.Complaint verification testing could not be performed as the actual sample was not returned for analysis.From the photo received by the customer, a hole was seen in the green cuff.This hole would likely result in a leak.However, without the physical sample, it cannot be determined at what point the damage may have occurred or if there are any other defects that contributed to the reported complaint.In addition, all et tubes are 100% inspected for inflation and deflation at the (con't.) other remarks: manufacturing site by inflating the cuffs and allowing them to remain inflated for four hours prior to being deflated.It is unlikely that this type of defect would have been present at manufacturing.A dhr review was performed on the et tube with no evidence to suggest a manufacturing related cause.It cannot be determined at what point the green cuff was damaged as the defect was discovered during use.

Event Description

The customer alleges that the device had an air leak from the balloon.

• Brand Name: RUSCH EASY TUBE, 41R
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5020760
• MDR Text Key: 23669355
• Report Number: 3003898360-2015-00565
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/28/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 180041
• Device Lot Number: 01H1100063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2011
• 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 Outcome(s): Death