MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, SHER-I-BRONCH, LS, 37 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Model Number IPN048996

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4); n/a; other remarks: n/a; corrected data: n/a.

Event Description

It was reported that "the doctor found cuff cannot be inflated when doing clinical setting before using on patient.Then changed new one, no impact on patient".No patient involvement.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.The photo was reviewed and the complaint could not be confirmed.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported that "the doctor found cuff cannot be inflated when doing clinical setting before using on patient.Then changed new one, no impact on patient".No patient involvement.

Event Description

It was reported that "the doctor found cuff cannot be inflated when doing clinical setting before using on patient.Then changed new one, no impact on patient".No patient involvement.

Manufacturer Narrative

(b)(4).The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.The et tube was returned with its stylet.The et tube was visually examined with and without magnification.Visual examination of the returned sample revealed that the et tube appears typical.No defects or anomalies were observed.A functional inspection was performed to attempt to inflate and deflate the balloon cuffs on the returned et tube.A syringe was filled with air and attached to the valve of the tracheal (white) pilot balloon.Upon injection of air, both the pilot balloon and cuff immediately inflated.The same process was used to test the bronchial (blue) inflation line.Once again, both the pilot balloon and cuff immediately inflated.The syringe was then removed and the cuffs and pilot balloons were inspected for leaks.No leaks were detected.The syringe was then reattached in order to deflate the balloons.All pilot balloons and balloon cuffs were able to deflate.The et tube was submerged underwater and an attempt to inflate the balloon cuffs was made in order to detect any leaks.Upon injection of air, no leaks were detected.No functional issues were found with the returned sample.The ifu for this product states, "the cuff inflation system (cuffs, pilot balloons, valves) should be checked by inflation and deflation prior to use.If cuff is damaged, the tube should not be used.Care should be taken to avoid damaging the cuffs during intubation.If any one of the cuffs is damaged, the tube should not be used." "cuff pressure should be monitored routinely to assure that an adequate seal is maintained and that the cuffs have not become over-inflated." "deflate all cuffs prior to repositioning the tube.Movement of the tube with cuffs inflated could result in patient injury or in damage to the cuffs, requiring a tube change.Verify the position of the tube after each repositioning." the reported complaint could not be confirmed based upon the sample received.The returned et tube was able to inflate and deflate with no difficulty.All et tubes are 100% inspected for both inflation and deflation at the time of manufacturing.A device history record review was performed and showed no evidence to suggest a manufacturing related issue.No functional issues were found with the returned device.

• Brand Name: ET TUBE, SHER-I-BRONCH, LS, 37 FR
• Type of Device: TUBE, TRACHEAL/BRONCHIAL, DIFF
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17139071
• MDR Text Key: 317269502
• Report Number: 3003898360-2023-00979
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 14026704617408
• UDI-Public: 14026704617408
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K180253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048996
• Device Catalogue Number: 5-16037
• Device Lot Number: 73K1900252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2019
• 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