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

Model Number	67N030
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff was not inflating correctly.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was 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 damaged could be detected.Sample was filled with 5cc of air in order to see if there was any functional problem.When inflating the unit with air, it was seen that cuff inflated but a part was not uniformly.The instruction for use(ifu) states that the cuff when manipulated the whole cuff inflated.However, extremely force was needed to inflate the cuff and after inflating the cuff it was seen that the teflon was not properly distributed inside the cuff.A review of the manufacturing process was conducted by quality engineer in order to verify that there are no situations or practices that could create the event and all procedures are being carried appropriate.The reported issue was confirmed.The teflon is not properly distributed.A corrective and preventative action has been opened to address the reported issue.As containment action production personnel were trained on quality alert.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA NEONATAL AND PEDIATRIC
• 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: 15418177
• Report Number: 3012307300-2022-19137
• Device Sequence Number: 2556664
• Product Code: JOH
• UDI-Device Identifier: 15021312006216
• UDI-Public: 15021312006216
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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 Expiration Date: 10/03/2022
• Device Model Number: 67N030
• Device Catalogue Number: 67N030
• Device Lot Number: 3515051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2017
• 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