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

Model Number IPN041701

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 305625542
• Report Number: 8040412-2022-00325
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 14026704344236
• UDI-Public: 14026704344236
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K141888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED