MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, HVT, 5.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10315
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported "the et tube connector disconnected and fell off".The patient's current condition is reported as "deceased".Additonal information was requested; however, no response has been received from the customer at this time.
Additional Manufacturer Narrative
Qn#(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.A dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A functional inspection of the product involved in the complaint could not be conducted since the product was not returned.Part number 5-10311 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 13 samples were dimensional inspected, and issue reported "detached - connector" was not observed in the current manufacturing process.All complaint are trended across product families on a monthly basis.Therefore, a separate complaint history review is not required.Dhr review could not be conducted since the lot number was not provided.Dhr review could not be conducted since the lot number was not provided.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported "the et tube connector disconnected and fell off".The patient's current condition is reported as "deceased".Additional information was requested; however, no response has been received from the customer at this time.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "detached - connector" could not be confirmed based on the returned sample.The returned connector was found to be within the acceptable specifications.However, preventative actions have been previously implemented at the manufacturing site to prevent this issue from occurring.A vision system was implemented to check for proper insertion depth of the connector.Procedures were also updated at the same time to add further inspection points and testing during production to ensure connectors are within specification.A lot number was not provided for this returned sample and no potential lot number could be found.Therefore, it could not be determined if the returned sample was manufactured prior to or after these preventative actions.Teleflex will continue to monitor and trend on this issue.

• Brand Name: ET TUBE, HVT, 5.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19018568
• Report Number: 3003898360-2024-00300
• Device Sequence Number: 3880381
• Product Code: BTR
• UDI-Device Identifier: 04026704397006
• UDI-Public: 04026704397006
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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
• Device Catalogue Number: 5-10315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown