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

Model Number	67PFSS50
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Samples received: one (1) samples was received in used conditions without its original packaging 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.No damaged could be detected.Functional test: sample was filled with air to see if there was any functional problem.When inflating the sample with air, it was seen that cuff inflated uniformly.The balloon was manipulated and the whole cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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 a new trach was put on the patient when the parent noticed that the patient started to desat.The patient then had to be bagged with a resus bag.They removed the trach and saw that it was not fully inflated.The patient's mother then tested the backup trach they had and found it would not fully inflate either so mom put the old trach back in the patient.The mother did not want to do this as the old trach has mold in it.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; minneapolis, MN 55442
• MDR Report Key: 15437013
• Report Number: 3012307300-2022-19405
• Device Sequence Number: 5836303
• Product Code: JOH
• UDI-Device Identifier: 10351688518712
• UDI-Public: 10351688518712
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 67PFSS50
• Device Catalogue Number: 67PFSS50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• 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): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown