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

Model Number	67PFSS55
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A picture was received for evaluation.The unit was inflated with water, cuff seemed asymmetrical.Three (3) samples were received in used conditions, with its certificate of safe handling and with its obturator.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.Air cuff symmetry test was performed to the unit.When inflating the units with air, the cuff inflated without problems but cuff seemed asymmetrical.When measuring the cuff, the percentage for the symmetry was for sample 1: 30%, sample 2: 43.90% and for sample 3: 36.68%.Result from sample 1 is below 33.3% that is the minimum acceptable.Based on the test, sample 1 is out of specification.The complaint was confirmed.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.The assembly process was performed according to the procedures listed above.The training was reviewed and it was confirmed that the personnel had the trainings up to date.All the inspections and verifications are being performed by the production personnel and verified by the quality inspectors.An internal corrective and preventative action was issued in order to determine the root cause and implement proper corrective actions.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported during pre-test, using 3ml of water, the cuff was found to be asymmetrical.Water was taken out of the cuff and reinserted with the same issue happening.No patient injury reported.

• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; beisenkampstr. 4; minneapolis, MN 55442
• MDR Report Key: 15433736
• Report Number: 3012307300-2022-19345
• Device Sequence Number: 5845420
• Product Code: JOH
• UDI-Device Identifier: 10351688518729
• UDI-Public: 10351688518729
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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: 67PFSS55
• Device Catalogue Number: 67PFSS55
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• 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: 07/06/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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