MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX UNIPERC INNER CANNULAE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO

Catalog Number	100/890/080CZ
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received that a smiths medical regarding a portex uniperc inner cannulae."when attempting to insert new inner tube it only went so far then kinked at neck of inner tube.Customer felt like the material was too soft and kept bending.Replaced it with the old inner tube." no adverse patient effects were reported.
Additional Manufacturer Narrative
Evaluation results: one used/decontaminated inner cannula 8 mm (007/522/108) was received in a plastic bag without its original packaging.Under visual inspection it was observed that the inner cannula was bent tubing close to its connector.This indicated that the cannula was bent several times.Based on the results of the investigation, the root cause of the complaint was not determined.

• Brand Name: PORTEX UNIPERC INNER CANNULAE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8525680
• Report Number: 3012307300-2019-01914
• Device Sequence Number: 19324208
• Product Code: BTO
• UDI-Device Identifier: 15019315107177
• UDI-Public: 15019315107177
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083031
• 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): 06/26/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 04/25/2023
• Device Catalogue Number: 100/890/080CZ
• Device Lot Number: 3629030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention