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

Catalog Number 5-16037

Device Problem Leak/Splash (1354)

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

Event Date 07/13/2023

Event Type  malfunction  

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.Involved 1 pc." no patient involvement.

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

Qn#(b)(4).The reported complaint of "leak - balloon cuff" was confirmed based upon the sample received.The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.The et tube and both double swivel connectors were returned out of their original packaging.One suction catheter was also returned in its original packaging.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appears typical.No defects or anomalies were observed.Functional inspection was performed to attempt to inflate and deflate the balloon cuffs on the returned et tube.A lab inventory syringe was filled with air.First, the syringe was connected to the bronchial (blue) pilot balloon.Using hand pressure, air was injected through the valve.Upon injection of air, the balloon cuff and pilot balloon were able to properly inflate.Next, the tracheal (white) inflation line was tested.Upon injection of the air, the balloon cuff was unable to inflate.The syringe was reconnected to the bronchial inflation line and the cuffs were able to properly deflate as well.The device was submerged underwater to detect any leaks.Upon injection of air, the tracheal balloon cuff leaked from a hole in the cuff.No other defects or anomalies were observed.The ifu for this product, was reviewed as a part of this complaint investigation.The ifu 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." a device history record review was performed, and no relevant findings were identified.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It was unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

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.Involved 1 pc." no patient involvement.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17429576
• MDR Text Key: 320122949
• Report Number: 3003898360-2023-01180
• 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
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5-16037
• Device Lot Number: 73E2200754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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