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

Model Number	ST15GN55NSC041S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two 5.5mm id customized fixed devices were returned for cuff not inflating.There was no excessive adhesive present in the airway line or cuff area.The teflon spray, used to keep the cuff from sticking, was not visible under the cuff.The lack of teflon spray allowed the cuff to stick to the shaft and prevented it from inflating.All product is 100% inspected and leak tested after manufacturing, prior to shipping to the customer.Per the dhr review, as recorded on st601, the device passed qa inspection.Issue quality alert qa18-007 to raise the operators' awareness of teflon dispensing.All affected manufacturing and quality operators trained to the quality alert.This remediation mdr was generated under protocol (b)(4)., as a result of warning letter (b)(4).
Event or Problem Description
It was reported that upon testing, the cuff would not inflate, and there was blockage in the balloon.Neither were used on a patient.No patient injury reported.

• Brand Name: BIVONA TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY
• 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: 15626599
• Report Number: 3012307300-2022-24851
• Device Sequence Number: 15008764
• Product Code: JOH
• UDI-Device Identifier: 10351688853318
• UDI-Public: 10351688853318
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: ST15GN55NSC041S
• Device Catalogue Number: ST15GN55NSC041S
• Device Lot Number: DS010934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/18/2022
• 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