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

Model Number	8.00MM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes adult aire-cuff malfunctioned when placed in the patient, two trach cuffs would not inflate.No patient adverse events reported.
Additional Manufacturer Narrative
Other text.Device evaluation: two 7.0 bivona air cuff devices were returned.Using the leak test procedure 20cc of air was applied to each device and submerged under water.There were no leaks detected on either device while the entire devices were manipulated under water.The cuff was filled with 20cc of air and allowed to rest for 4 hours.There was a slight loss of volume, which is expected with silicone air cuff devices.The complaint stated, ?when placed in the patient, two trach cuffs would not inflate?.All air device cuffs are 100% leak tested to prior to packaging.The instruction for use states to use either minimal leak or minimal occlusive volume techniques to establish the cuff and to ensure correct inflation at regular intervals.This investigation did not confirm the complaint or reveal any intrinsic manufacturing defects with the returned device.
Event or Problem Description
Additional information provided that the patient's trach tube was changed.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10442941
• Report Number: 3012307300-2020-08408
• Device Sequence Number: 4044525
• Product Code: JOH
• UDI-Device Identifier: 15021312006414
• UDI-Public: 15021312006414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: Health Professional
• Device Expiration Date: 08/29/2023
• Device Model Number: 8.00MM
• Device Catalogue Number: 750170
• Device Lot Number: 3680793
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/14/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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: 45 YR