MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTI

Model Number	IPN041700
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Complaint reports that: "female patient, submitted to thoracotomy by video thoracoscopy and pleurodesis, where left broncho-cath tube #35 is used, which fails during surgery.Tube presents perforation in the cuff, so a change is requested to perform the procedure.".
Additional Manufacturer Narrative
(b)(4).The actual sample was returned for evaluation.A visual exam was performed and no defects were observed.The pressure of the clear cuff and the blue cuff of the device were then tested by inflating the cuffs to 25 mbar using a calibrated endotest.It was observed that the clear cuff was able to maintain pressure at 25mbar; however, the blue cuff would not stay inflated.A water leak test was then conducted on the returned sample by immersing it underwater.Bubbles were observed flowing out from the blue cuff indicating a leak.The area of leakage was observed under magnification and a cut mark was observed on the cuff.A device history record review was performed and no relevant findings were identified.The complaint of leakage was confirmed; however, a root cause for the issue could not be determined.There is a 100% inflation and leak test conducted at the manufacturing facility whereby any defects would be detected prior to release.It is possible that the failure could be induced during product handling by the user, although this could not be confirmed.Corrected data: section d.1.-brand name corrected to rusch double lumen bronchial tube set left.
Event or Problem Description
Complaint reports that: "female patient, submitted to thoracotomy by video thoracoscopy and pleurodesis, where left broncho-cath tube #35 is used, which fails during surgery.Tube presents perforation in the cuff, so a change is requested to perform the procedure." no patient injury or consequence reported.The current condition of the patient was reported as "fine".

• Brand Name: RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTI
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• 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 ; 9193614124
• MDR Report Key: 15536628
• Report Number: 8040412-2022-00285
• Device Sequence Number: 6073730
• Product Code: CBI
• UDI-Device Identifier: 14026704344229
• UDI-Public: 14026704344229
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K141888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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 Expiration Date: 03/28/2026
• Device Model Number: IPN041700
• Device Catalogue Number: 116100350
• Device Lot Number: KME21D2377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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 Sex: Female