MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA MID-RANGE AIRE-CUF ADULT TRACH TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	750170
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	02/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
Event or Problem Description
It was reported that while the patient's spouse was attempting to change a cannula but, the spouse noted the replacement cannula had a dysfunctional cuff (asymmetric cuff and not allowing adequate ventilation).They therefore took the last cannula (with no anomaly) and was able to make a change of cannula, resolving the reported event.
Additional Manufacturer Narrative
Other, other text: no lot number was provided; therefore, device history record review could not be performed.A product sample and four (4) photos were received for evaluation.Visual inspection of the photos show evidence of cuff rupture.Visual inspection of the sample found damage (cuff ruptured).Failure reported could not be reproduced using the tools from assembly process.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.D4 device lot number is unknown, no information provided to date.D5 and e4 are unknown, no information provided to date., corrected data: b1: adverse event, h1: serious injury.

• Brand Name: BIVONA MID-RANGE AIRE-CUF ADULT TRACH TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13710677
• Report Number: 3012307300-2022-04402
• Device Sequence Number: 5333354
• Product Code: JOH
• UDI-Device Identifier: 15021312006414
• UDI-Public: 15021312006414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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
• Device Model Number: 750170
• Device Catalogue Number: 750170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 65 KG