MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/136/050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the month (march) and year (2021) of the event date are known.(b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that immediately after using the portex endotracheal tube, the cuff was failing to inflate.No patient injury or complications were reported in relation to this event.Additional information was requested but has not yet been received.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
Device evaluation completed and will generated a follow up report.Jm.
Additional Manufacturer Narrative
Other text: investigation completed on a smiths medical intubation|portex endotracheal tubes polar complaint of unable to inflate cuff was confirmed.Four photos received and sample was returned for evaluation p/n 100/136/050.Visual inspection revealed excess thf at the joint between.During inflation occlusion was detected at the joint between.Based on the analysis conducted in the sample provided, cuff inflation and deflation failure mode was confirmed.Therefore, according to on pfmea (rmp 1051) the occurrence of this failure condition could be caused by excessive solvent in the joint.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11752883
• Report Number: 3012307300-2021-03635
• Device Sequence Number: 4138826
• Product Code: BTR
• UDI-Device Identifier: 15019315021053
• UDI-Public: 15019315021053
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 08/01/2022
• Device Model Number: 100/136/050
• Device Catalogue Number: 100/136/050
• Device Lot Number: 3475255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1