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

Model Number	35W070
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex endotracheal tubes siliconized is not inflating symmetric fully in cuff.Unknown if patient adverse events occurred.
Event or Problem Description
Investigation completed and summary in h 10.
Additional Manufacturer Narrative
Other, other text: investigation completed on a smiths medical intubation|portex endotracheal tubes siliconized cuff inflation was not symmetric of eleven samples upon testing and complaint could not be confirmed.There were no abnormalities found during the visual inspection of the returned samples.Using a standard syringe, 20 ml of air was inserted into the airway lines of the returned devices.

• Brand Name: BIVONA
• Common Device Name: TUBE, ENDOTRACHEAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11856386
• Report Number: 3012307300-2021-04723
• Device Sequence Number: 3173137
• Product Code: BTR
• UDI-Device Identifier: 15021312014365
• UDI-Public: 15021312014365
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K792035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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 Model Number: 35W070
• Device Catalogue Number: 35W070
• Device Lot Number: 3952240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1