MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY

Model Number	9.0MM
Medical Device Problem Codes	Peeled/Delaminated (1454); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes custom malfunctioned after inserting the cannula into the tracheostoma, it was noticed that the proximal foam cuff has drawn together, wrinkles and no longer expands to its original shape.The issue was noticed after 72 hours in use.Pictures were attached.No patient adverse events were reported.
Additional Manufacturer Narrative
Other, other text: device evaluation- one device was returned for evaluation.The device was visually inspected; this showed no issues with the proximal cuff but the distal cuff appeared baggy around the foam core.The physical condition of the returned device was determined consistent with the foam cuff having been exposed to fluid.The device was given leak testing; no leaks were identified during testing.The investigation determined it was likely that during sterilization or reprocessing by user the red plug for the distal cuff was not secured and water or steam entered into the inflation line.The instruction for use states the following note under section 8.0 cleaning: "note: for fome-cuf products make sure the fome-cuf/stoma seal is fully expanded and then plug the red wing pilot port prior to cleaning to prevent fluids from wetting the foam." the distal cuff was measured and found to meet with specifications.The reporter provided device photographs: review of the photographs determined the device was not being used properly.The distal foam cuff is intended to be a cushion, which lays on top of the stoma.It usually is bigger than the stoma and is used to cover a large and/or irregular stoma.The picture shows the distal cuff being inserted into the stoma.Second, since the template required no red plug for the proximal cuff, the foam became condensed when the air diffused from the silicone cuff and was not able to rebound instantaneously via the red plug line.The investigation determined the device was built as per the physician's template and functioned appropriately.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11484697
• Report Number: 3012307300-2021-02074
• Device Sequence Number: 3431021
• Product Code: JOH
• UDI-Device Identifier: 15019517251319
• UDI-Public: 15019517251319
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• 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): 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2025
• Device Model Number: 9.0MM
• Device Catalogue Number: SF20LN90ZTZ042N
• Device Lot Number: GA013842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1