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

Model Number	67NFP40
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three product samples were received for evaluation.Visual and functional testing were performed.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.No discrepancies were found.Samples were filled with 5cc of air in order to see if there was any functional problem.The sample were inflated, sample 1 and 2 with air, the cuff only inflated one side.According to the instruction for use(ifu), the pilot balloon was manipulated and the cuff inflated completely.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.When the sample 3 was inflated, the pilot balloon inflated but all air was stuck in it.According to the ifu, the pilot balloon was manipulated and the cuff inflated completely.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.Air cuff symmetry test was performed to the unit.When the cuffs were measured the cuffs, the percentage for the symmetry for sample 1: 37.83%, for sample 2: 29.41 and for sample 3: 36.11%.These results are below 33.3% that is the minimum acceptable.Based on the test, the unit 2 is out of spec.The complaint is confirmed.A corrective and preventative action has been opened to address root cause and actions.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that three trach tube cuffs are not inflating properly despite cuff manipulation.No patient injury was reported.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15437943
• Report Number: 3012307300-2022-19460
• Device Sequence Number: 17535168
• Product Code: JOH
• UDI-Device Identifier: 10351688518767
• UDI-Public: 10351688518767
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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
• Operator of Device: Health Professional
• Device Model Number: 67NFP40
• Device Catalogue Number: 67NFP40
• Device Lot Number: 3861138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown