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

Model Number	100/899/070CZ
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign report source: (b)(6).
Event or Problem Description
Information was received that the blue locksystem on a smiths medical regarding a portex uniperc inner cannula did not work.No adverse patient effects were reported.
Additional Manufacturer Narrative
Investigation results completed on a smiths medical tracheostomy|pvc - portex tubes pdt uniperc.Device received 7mm in plastic bag with photos provided.When inspecting devcie it was confirmed the blue locking lever is incorrectily screweed with flange body which was causing the issue.We unscrewed locking lever from flange body and assembled it back correctly.We can confirm that after correct assembly locking mechanism works well (see attached photo of sample after repair).Similar customer complaints where the same issues related to uniperc flange locking mechanism were raised in past and therefore pattern object ptn-00039 was created.This issue was escalated to complaint trend process as per dvsop5007 and is tracked uner review-101279.No finding in the dhr when reviewing manufacturing.
Event or Problem Description
Investigation completed on on a smiths medical tracheostomy|pvc - portex tubes pdt uniperc.
Additional Manufacturer Narrative
B5 and h6 were updated to reflect no patient involvement.
Event or Problem Description
Information was received that the blue lock system on a smiths medical regarding a portex uniperc inner cannula did not work.No patient involvement.

• 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
• MDR Report Key: 9833561
• Report Number: 3012307300-2020-02018
• Device Sequence Number: 2929135
• Product Code: BTO
• UDI-Device Identifier: 15019315107221
• UDI-Public: 15019315107221
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Followup
• Report Date (Section B): 07/11/2020

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: No Information
• Device Expiration Date: 07/26/2024
• Device Model Number: 100/899/070CZ
• Device Catalogue Number: 100/899/070CZ
• Device Lot Number: 3827426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 03/24/2020; 03/24/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/23/2020; 07/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1