MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD. PURITAN BENNETT; CUFF, TRACHEAL TUBE, INFLATABLE

Model Number	180-03
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 2261-2752e tracheostomy tube (ace) (lot# unknown).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, the tracheostomy tube was accidentally removed from the patient during use.It was stated that the cuff was slightly inflated.When the tube was removed, air was injected in the cuff and spontaneously came out.It was dipped into the water and a pinhole was detected.The cuff pressure was also reported to not alarm or it did not sound when the issue happened.The tube was replaced.
Additional Manufacturer Narrative
Additional information: b5, d4, d9, g1, g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the cuff pressure monitor was reported not alarmed or did not sound when the tube was accidentally removed from the patient during use.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, the trach tube was accidentally removed from the patient during use.It was stated that the cuff was slightly inflated.When the tube was removed, an air was injected in the cuff and spontaneously came out.It was dipped into the water and a pinhole was detected.The cuff pressure was also reported not alarmed or did not sound when the issue happened.The tube was replaced.

• Brand Name: PURITAN BENNETT
• Common Device Name: CUFF, TRACHEAL TUBE, INFLATABLE
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin 11900 ; MY 11900
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 19711614
• Report Number: 3004593495-2024-00011
• Device Sequence Number: 8514535
• Product Code: BSK
• UDI-Device Identifier: 10884521782495
• UDI-Public: (01)10884521782495(11)231114(21)E234600094
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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 Model Number: 180-03
• Device Catalogue Number: 180-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11
• Patient Sex: Unknown