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

Model Number	67SP040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuffs are not inflating on smiths medical trach tubes and seeming to stick to one side.Takes a lot of manipulation and sterile water to inflate the cuff.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other text: investigation completed on a smiths medical tracheostomy|silicone - bivona tubes neo/ped received a sample from two p/n 67sp040 l/n 3763982 and p/n 67sn035, l/n 3949041 were testing following ifu instruction.The pressures : 44.11% and sample 2:42.10%.These results are over 33.3% that is the minimum acceptable.Based on the test, the units are within spec.The complaint is not confirmed.The complaint was not confirmed.
Event or Problem Description
Investigation completed and summary in h 10.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11795369
• Report Number: 3012307300-2021-04099
• Device Sequence Number: 3181901
• Product Code: JOH
• UDI-Device Identifier: 15021312000726
• UDI-Public: 15021312000726
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/09/2021

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: Other
• Device Model Number: 67SP040
• Device Catalogue Number: 67SP040
• Device Lot Number: 3763982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 05/08/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1