• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL HUDSON ET TUBE, SHER-I-BRONCH, LS, 37 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF Back to Search Results
Model Number IPN048996
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2023
Event Type  malfunction  
Event Description
Reported issue: the doctor found cuff cannot be inflated before using it on the patient; it was changed to a new one.There was no impact on the patient.
 
Manufacturer Narrative
Qn#(b)(4).The actual sample was not returned; however, the customer provided a photograph for evaluation.A visual exam was performed on the photograph and the failure mode was unable to 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
Reported issue: the doctor found cuff cannot be inflated before using it on the patient; it was changed to a new one.There was no impact on the patient.
 
Manufacturer Narrative
(b)(4).The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.The et tube and stylet were both returned out of their original packaging.Both double swivel connectors (tracheal and bronchial) and the y connector were returned in their original packaging.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.A device history record review was performed and no relevant findings were identified.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON 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
9194332672
MDR Report Key16616141
MDR Text Key312105463
Report Number3003898360-2023-00393
Device Sequence Number1
Product Code CBI
UDI-Device Identifier14026704617408
UDI-Public14026704617408
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K180253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN048996
Device Catalogue Number5-16037
Device Lot Number73E2200756
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
-
-