MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT

Model Number	IPN041700
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Unintended Extubation (4564); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that while in use on a patient, "the pediatric bronchoscope doesn't go well inside the ett".As a result, the patient was extubated and re-intubated with another ett.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn#(b)(4) the sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "to simulate the descri ption, guidewire from the set was used to replicate the bronchoscope.Few attempts to insert the guidewire into the main tube through both tracheal and bronchial connector found no obstacle.Therefore complaint could not be confirmed as per reported.In current procedure following spm-p52-062 rev 13, during primary process each tube shall go through tube curving process whereby each of the extruded tube shall be inserted to the former and put into oven of 165 5 c for 8 min.Lumen id inspection also was conducted with id inspection gauge with criteria of the id inspection gauge shall glide easily into lumens without any construction.All rejects shall be culled out and disposed accordingly before product released to next process." the customer did not provide the actual lot number of the device, but did report a potential lot.A device history record review was performed on the potential lot number and no relevant findings were identified.The complaint could not be confirmed.There were no issues found with the returned device.Other remarks: n/a.Corrected data: section d.3.- manufacturer corrected to teleflex medical, athlone, wm.
Event or Problem Description
It was reported that while in use on a patient, "the pediatric bronchoscope doesn't go well inside the ett".As a result, the patient was extubated and re-intubated with another ett.Additional information received on 5 may 2023 states that "the patient did not desaturate.There was no harm to the throat nor the superior airway.The problem was the impossibility to confirm proper positioning because the bronchoscope could not enter the tube.The problem did not occur during the intubation, but while verifying proper positioning in the bronchus for surgery.They had to extubate the patients to change the dbl tube to be able to enter the bronchoscope in the tube.Therefore, an extubating process was needed and then reintubation (unnecessary if the problem did not occurred with the left 35 dbl tube".

• Brand Name: RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
• Common Device Name: BRONCHIAL TUBE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone NC
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16824267
• Report Number: 8040412-2023-00180
• Device Sequence Number: 12479631
• Product Code: CBI
• UDI-Device Identifier: 14026704344229
• UDI-Public: 14026704344229
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: Health Professional
• Device Model Number: IPN041700
• Device Catalogue Number: 116100350
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/30/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Female