MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX PERC DILATION KIT W/ SINGLE STAGE DILATOR & BLUSELECT SUCTIONAID TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/563/080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	03/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A5.Ethnicity: british.D4.Lot number, expiration date, and h4.Manufacture date are unknown; no information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no lot number was received.
Event or Problem Description
It was reported that the patient was unable to or having difficulty in aspirating from the subglottic port due to broken plastic.The patient was undergoing long term ventilatory wean.The patient was sedated and unable to be weaned off the ventilator due to a multitude of factors.Percutaneous tracheostomy insertion was performed as a result.The tracheostomy was changed or removed when clinically appropriate.The event occurred in the intensive care unit.There were no reports of any harm caused, but it was difficult to manage patient's respiratory wean due to secretion load above the cuff.No further medical intervention was required.

• Brand Name: PORTEX PERC DILATION KIT W/ SINGLE STAGE DILATOR & BLUSELECT SUCTIONAID TUBE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19984774
• Report Number: 3011237704-2024-00165
• Device Sequence Number: 4325290
• Product Code: BTO
• UDI-Device Identifier: 15019517103410
• UDI-Public: (01)15019517103410
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173912
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101/563/080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 84 KG
• Patient Race: Black Or African American