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

Model Number	FT20AN40NSE087N
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the size disappeared before the reprocessing cycle.Additional information was received indicating that the obturator was distorted and melted during post cleaning.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was unable to be performed since no lot number was provided.The provided picture showed a melted obturator and did not show the neck flange where the print is applied.Two devices were returned: sample one appeared to have been older / used more due to the discoloration / yellowing of the silicone than sample 2.Visual inspection of the two returned device showed that the print on the neck flange and was clearly visible.Neck flanges on custom devices are screen printed and a sealant is applied to the print to mitigate removal, it is likely the sealant was either not applied or the solution/cleaner that was applied to the device removed the sealant and print.The review of the returned obturators could not identify the cause of the distortion.The plastic handle appeared to be melted by a chemical rather than heat, but could be a combination of an inappropriate solution / cleaner and heat.Since no information on what was used to clean or the method used to reprocess the devices was provided by the complainant, a root cause could not be determined solely on examining the returned sample.This is the first complaint of an obturator melting.No corrective actions are planned at this time.Operator of device: unknown this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX
• 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: 15470553
• Report Number: 3012307300-2022-20192
• Device Sequence Number: 4468655
• Product Code: JOH
• UDI-Device Identifier: 15019517218299
• UDI-Public: 15019517218299
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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
• Device Model Number: FT20AN40NSE087N
• Device Catalogue Number: FT20AN40NSE087N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• 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: 07/10/2022
• Initial Report FDA Received Date: 09/23/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown