MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX UNIPERC REPLACEMENT INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/890/080CZ
Medical Device Problem Codes	Material Discolored (1170); Defective Component (2292)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the incident occurred when an incorrect inner cannula cleaning brush was found lodged in the patient¿s left main bronchus after an episode of desaturation and acute respiratory distress.There was patient involvement and patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: date of event is unknown.D4: lot number is unknown.H3 other: device has not been returned to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
The following field was updated with corrections: d4.Primary udi number: (b)(4).Investigation codes: updated.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.Investigation of this complaint was done based on photos provided by customer.On the photo are the following components: - tube & flange assembly, cuffed, uniperc, 8mm p/n 007/842/080cz - inner cannula cleaning swab (size 7, 8, 9) ¿ uniperc p/n 005/073/930 - inner cannula - uniperc, 8mm p/n 007/522/108 - 8mm blu thin wall inner cannula, p/n 005/073/680 - trachy tube holder with cleaning brush p/n 005/080/008 the components 8mm blu thin wall inner cannula, p/n 005/073/680 and trachy tube holder with cleaning brush p/n 005/080/008 are incorrect as stated by the customer.These parts are not included in the package of uniperc tube.They are used for a different type of product ¿ for blu tracheostomy tube.Uniperc products are sold together with cleaning swabs 005/073/930.Based on above rationale this issue is considered to be caused by human error during use.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.

• Brand Name: PORTEX UNIPERC REPLACEMENT INNER CANNULA
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19214312
• Report Number: 3012307300-2024-03182
• Device Sequence Number: 8138743
• Product Code: BTO
• UDI-Device Identifier: 15019315107177
• UDI-Public: (01)15019315107177
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083031
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: 100/890/080CZ
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/18/2024
• 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