MAUDE Adverse Event Report: HUDSON ET TUBE, HVT, 8.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048897
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 315 samples were taken from the current production (material # 00003-16 lot # 3118713), the samples were inspected according to qip, the revised characteristics comply with the requirement.Defect reported "torn/ruptured - cuff" was not observed in the current manufacturing process.A device history record review could not be conducted since the lot number of the device was not provided.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 or Problem Description
It was reported "cuff of the endotracheal tube was completely blown and the patient had to be reintubated".No patient injury or harm reported.Unknown patient condition at time of report.
Event or Problem Description
It was reported "cuff of the endotracheal tube was completely blown and the patient had to be reintubated".No patient injury or harm reported.Unknown patient condition at time of report.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10316 et tube, hvt, 8.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that there are multiple holes in the balloon cuff which would prevent the cuff from inflating.Dimensional inspection was performed on the thickness of the balloon cuff.The thickness of the balloon cuff at the end of the cuff where it is adhered to the tube should be.008" +/-.003".The thickness of the cuff at this spot was measured to be.01025", which was within the allowable tolerances.Additionally , the balloon cuff was cut open to measure the thickness at the middle of the cuff.The cuff was measured to be.003" which was within specifications.No dimensional issues were observed.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." the ifu also states, "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 was confirmed based upon the sample received.The returned et tube was found to have multiple holes in the balloon cuff which would prevent the cuff from staying fully inflated.A device history record review was performed with no evidence to suggest a manufacturing related cause.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 is 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.

• Brand Name: HUDSON ET TUBE, HVT, 8.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• MDR Report Key: 12518684
• Report Number: 3003898360-2021-00887
• Device Sequence Number: 4290939
• Product Code: BTR
• UDI-Device Identifier: 14026704616760
• UDI-Public: 14026704616760
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: IPN048897
• Device Catalogue Number: 5-10316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.