MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL SILICONE BIVONA ADULT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670150
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that while a smiths medical tracheostomy was in use, the cuff was noted to have a pinhole leak.This resulted in a tracheostomy tube change out.No fadverse effects reported.
Additional Manufacturer Narrative
Eight tracheostomy tubes were received for evaluation.Upon visual inspection of the eight cuffs, they were noted to have tiny scratches next to the small holes on the cuffs.Perhaps caused by the device coming into contact with something sharp externally or potentially from hard cartilage internal to the patient.The holes and scratches align in the same locations on the cuffs with all eight samples.Device underwent leak testing by filling cuffs with 20cc of air.It was noted that the cuffs were unable to fully inflate and immediately deflated as air escaped from a small hole in the cuffs.The reported customer complaint has been confirmed, however a problem source has not been determined.

• Brand Name: SMITHS MEDICAL SILICONE BIVONA ADULT TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9158809
• Report Number: 3012307300-2019-05472
• Device Sequence Number: 2138953
• Product Code: JOH
• UDI-Device Identifier: 15021312006025
• UDI-Public: 15021312006025
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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 Catalogue Number: 670150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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
• Patient Age: 27 YR