MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA ENDOTRACHEAL TUBE; 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.
Additional Manufacturer Narrative
Device evaluation: eleven samples were received for evaluation.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.There were no issues identified with the cuffs inflating.A standard ruler was used to measure cuff symmetry on the devices.Locating the position of the worst case symmetry, measurements were taken from the outside of the cuff to the center of the shaft and then from the center of the shaft to the opposite outside of the cuff.The following are the measurements recorded for each device: sample 1 - 20mm/10mm, sample 2 - 15mm/12mm, sample 3 - 19mm/11mm, sample 4 - 17mm/12mm, sample 5 - 15mm/13mm, sample 6 - 15mm/15mm, sample 7 - 17mm/13mm, sample 8 - 18mm/13mm, sample 9 - 20mm/10mm, sample 10 - 20mm/11mm and sample 11 - 18mm/12mm.All measurements meet the manufacturing specification of 1/3:2/3.The reported problem could not be confirmed.

• Brand Name: BIVONA ENDOTRACHEAL TUBE
• Common Device Name: TUBE, ENDOTRACHEAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11856479
• Report Number: 3012307300-2021-04725
• Device Sequence Number: 19580767
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 3782467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• 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: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1