MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUE LINE ULTRA SUCTIONAID WITH INNER CANNULA, 8 MM; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/870/080
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that cuff can't inflate.Event occurred immediately on use, in the hospital.Patient involvement is unknown.
Additional Manufacturer Narrative
D9: date returned to mfg.: 3/27/2024.One decontaminated device sample was returned for investigation.An inflation test was performed, and it was found that it is not possible to inflate the sample because it leaked.Under visual inspection tear in the cuff was noticed which caused reported leakage.Because the cuff leak was observed after placement it is the most probable that the reported failure occurred during tracheostomy procedure due to contact with sharp edge which conflicts with instruction for use.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No trend of confirmed complaints in relation to this issue was identified.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID WITH INNER CANNULA, 8 MM
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18937498
• Report Number: 3011237704-2024-00066
• Device Sequence Number: 6971551
• Product Code: BTO
• UDI-Device Identifier: 15019315038808
• UDI-Public: (01)15019315038808(17)271125(10)4339536
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: 100/870/080
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 4339536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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: Unknown