MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX UNIPERC ADJUSTABLE FLANGE CUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/897/090CZ
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received that a smiths medical portex uniperc adjustable flange cuffed tracheostomy tube cuff leaked near the base of the tracheostomy (trach) tube immediately on use.No clinical consequences to the patient were reported.
Event or Problem Description
Additional information was received that a tracheostomy (trach) change out was required.
Additional Manufacturer Narrative
One tracheostomy was returned evaluation.Visual inspection of the device found it to be in good physical condition.During the manufacturing process the uniperc devices are 100% inflation tested.The inflation test was used as functional testing on the returned sample.After 12 hours, the cuff was noted to be significantly deflated.The sample was then submerged under water, and cuff was inflated using a syringe.Air was observed to be leaking from the place where inflation line is connected with the inflation lumen.The most probable cause of issue was determined to be that the flange was pulled above the last marking, puncturing the lumen.It was determined that the reported customer complaint has been confirmed.

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE CUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8186332
• Report Number: 3012307300-2018-08913
• Device Sequence Number: 1406829
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: 15019315107214
• 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: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2019

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/12/2022
• Device Model Number: 100/897/090CZ
• Device Catalogue Number: 100/897/090CZ
• Device Lot Number: 3431839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 12/21/2018; 03/11/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/18/2019; 03/27/2019
• 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