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

Model Number	IPN041701
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: before applying anesthesia, the specialist verified the bronchial cuff by trying to inflate it and it deflated by itself.As being unable to seal it had to be replaced.There was no reported injury.
Additional Manufacturer Narrative
Qn# (b)(4).It was reported that "before applying anesthesia, the specialist verified the bronchial cuff by trying to inflate it and it deflated by itself.As being unable to seal it had to be replaced." no actual sample was received, only a photograph provided in sap and a visual inspection was conducted on the photograph.Further investigation such as inflation and deflation test on the sample could be performed.Hence, defect mode could not be confirmed.In conclusion, based on the photograph provided in sap, the defect mode of sample deflated by itself could not be confirmed.
Event or Problem Description
Reported issue: before applying anesthesia, the specialist verified the bronchial cuff by trying to inflate it and it deflated by itself.As being unable to seal it had to be replaced.There was no reported injury.

• Brand Name: DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
• Common Device Name: BRONCHIAL TUBE
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15828405
• Report Number: 8040412-2022-00325
• Device Sequence Number: 6223264
• Product Code: CBI
• UDI-Device Identifier: 14026704344236
• UDI-Public: 14026704344236
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K141888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2026
• Device Model Number: IPN041701
• Device Catalogue Number: 116100370
• Device Lot Number: KME21J0786
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown