MAUDE Adverse Event Report: SLICK SET CUFFED 7.0MM; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN040783
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "tube size was a size 7.Able to intubate patient.After an hour customer noticed that the connector pops off our et tube.Condition of patient is they are home.Medical intervention was needed.Patient was not harmed or injured.Patient did experience desaturation.Problem was solved.They did not extubate then intubate".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The connector assembly features of the et tube were designed in such a way that the connector can be removed and connected back to the tube when the tube is required to be cut to length.There is a precaution stated in the ifu that the 15mm connector should be firmly seated in the tracheal tube to prevent disconnection during use.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.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.
Event or Problem Description
It was reported "tube size was a size 7.Able to intubate patient.After an hour customer noticed that the connector pops off our et tube.Condition of patient is they are home.Medical intervention was needed.Patient was not harmed or injured.Patient did experience desaturation.Problem was solved.They did not extubate then intubate".
Event or Problem Description
It was reported "tube size was a size 7.Able to intubate patient.After an hour customer noticed that the connector pops off our et tube.Condition of patient is they are home.Medical intervention was needed.Patient was not harmed or injured.Patient did experience desaturation.Problem was solved.They did not extubate then intubate".
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however the customer sent back an unopened representative sample for evaluation.A visual exam was performed on the returned sample and no obvious defects were observed.The insertion depth of the connector was then measured and was found to be 8mm, which meets the criteria of the connector needing to be partially inserted into the tube.The connector assembly features of the endotracheal tube was designed in such a way that the connector can be removed and connected back to the tube when the tube is required to be cut to length.There is a precaution stated in the ifu that the 15mm connector should be firmly seated in the tracheal tube to prevent disconnected during use.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, no issues were found with the returned representative sample.However, without the actual device to evaluate the complaint could not be confirmed and a probable cause could not be determined.The actual sample is needed to perform a proper investigation.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.1.-brand name corrected to slick set cuffed 7.0mm.Section d4: catalog# corrected to 170070.Section d4: udi# corrected to (b)(4).

• Brand Name: SLICK SET CUFFED 7.0MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• MDR Report Key: 11488000
• Report Number: 8040412-2021-00079
• Device Sequence Number: 11731784
• Product Code: BTR
• UDI-Device Identifier: 14026704340870
• UDI-Public: 14026704340870
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K961840
• 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,Followup
• Report Date (Section B): 02/24/2021

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
• Operator of Device: No Information
• Device Expiration Date: 06/28/2025
• Device Model Number: IPN040783
• Device Catalogue Number: 170070
• Device Lot Number: 20GG36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 09/23/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/14/2021; 09/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention