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

Model Number	67PFPS45
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device's cuff was leaking.No patient injury was reported.
Event or Problem Description
It was reported the device's cuff was leaking.No patient injury was reported.
Additional Manufacturer Narrative
Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: samples received: one (1) sample was received from p/n 67pfps45 l/n unknown without its original packaging inside a ziploc bag, in used conditions and without its certificate of decontamination.Visual inspection: visual inspection was performed at 12? under normal lighting to received unit, in order to detect any damage on the cuff, airline or pilot balloon.Results: no damaged could be detected.Functional test: the sample was tested on leak test.The test was performed under water as per mp bivona tt-tj130 rev.102 ? wi-mfg./inspect instructions and av-10006853 rev.101 - leak testing and cuff symmetry visual aid.Results: we inflated the unit, and we visually inspected it for 10 seconds, we did not observe any leakage.Then we submerged the unit under water, we did not observe any leakage.We were following massaging the cuff, we squeezed it and we moved the airway line back and forth.We did not detected any leaks during the test.Based on the analysis conducted in the sample provided, the complaint was not confirmed.No corrective actions were taken since the complaint was not confirmed.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

• Brand Name: BIVONA
• 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: jim vegel ; 6000 nathan lane north; ashton health centre; minneapolis, MN 55442
• MDR Report Key: 13583242
• Report Number: 3012307300-2022-03897
• Device Sequence Number: 12173370
• Product Code: JOH
• UDI-Device Identifier: 10351688518552
• UDI-Public: 10351688518552
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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
• Device Model Number: 67PFPS45
• Device Catalogue Number: 67PFPS45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 06/02/2022
• 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
• Patient Sex: Unknown