MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE CUFF; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	100/897/090CZ
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One sample of 007/522/109 inner cannula - uniperc, 9 mm and one sample of 007/842/090cz tube and flange assembly, cuffed, uniperc, 9 mm were received in plastic bag for investigation without its original packaging.Under initial visual inspection the sample appeared to be in good condition.Then the sample was submerged in water and the tracheostomy tube cuff was inflated using a syringe filled with air.No leaking was observed.During the manufacturing process the uniperc devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received sample.After 12 hour period the cuff was still fully inflated.
Event or Problem Description
It was reported that the cuff could not maintain enough pressure for ventilation.In addition, removal was made difficult due to the cuff not deflating.Attempts to inflate/deflate with a syringe resulted only in inflating/deflating the blue pillow.There was no air entry or exit from the cuff.The initial reporter stated that there was a query valve malfunction.The aforementioned issues occurred 13 hours after the tracheostomy tube was placed.The initial reporter also noted that there was "potential trauma caused to trachea, but this was not observable." an investigation was performed into the incident above by the facility.The investigation was unable to confirm the complaint.

• Brand Name: UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE CUFF
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7503691
• Report Number: 3012307300-2018-01370
• Device Sequence Number: 105542
• Product Code: JOH
• UDI-Device Identifier: 15019315107214
• UDI-Public: 15019315107214
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/09/2018

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: Nurse
• Device Expiration Date: 07/17/2017
• Device Catalogue Number: 100/897/090CZ
• Device Lot Number: 3448556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/10/2018
• 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: Other