MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CUFFED FLEX D.I.C TRACHEOSTOMY TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	505080
Medical Device Problem Codes	Contamination (1120); Residue After Decontamination (2325)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical portex cuffed flex d.I.C tracheostomy tube pilot balloon was black on the inside and slightly went up the tube.The issue was discovered upon cleaning.It was also reported the patient was still using the device until a routine tracheostomy change out was performed.There were no adverse patient effects.
Additional Manufacturer Narrative
Evaluation results: one portex tracheostomy tube was returned for investigation in used condition.Visual inspection revealed a dark discoloration of the inflation balloon extending approximately 2 inches into the inflation line.The customer reported product problem was therefore confirmed.A leak test determined that there was no leakage.To allow further inspection of the discolored pilot balloon, the balloon was cut opened to inspect the inside surface.The intent was to determine if the discoloration was the result of an introduced substance that was loose inside the balloon, or if it was a characteristic of the material itself.The discoloration was determined to be characteristic of the material itself.No loose substance was present on the inside of the pilot balloon.It appeared that the material of the pilot balloon and the inflation line changed coloration from an unknown cause.As an attempt to replicate the issue, a portion of the inflation line, without discoloration, was removed (cut away) and was placed in a vessel containing chlorine bleach.The sample was submerged in the bleach overnight.When the sample was inspected, it showed signs of discoloration at each end that was very similar to that of the inflation balloon of the returned sample.Because the customer stated (within the attached correspondence) that the discoloration was not evident until after the trach tube had been used on the patient, this may suggest that the cause for the discoloration may have originated from, or perhaps was a reaction to an introduced substance (i.E., cleaning solutions or a residual solution from a syringe used for inflation).While the discoloration was observed on the returned sample, the cause for this discoloration could not be determined with any certainty.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: PORTEX CUFFED FLEX D.I.C TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8822325
• Report Number: 3012307300-2019-02851
• Device Sequence Number: 19676392
• Product Code: BTR
• UDI-Device Identifier: 10351688021007
• UDI-Public: 10351688021007
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2020

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: No Information
• Device Expiration Date: 05/31/2022
• Device Model Number: 505080
• Device Catalogue Number: 505080
• Device Lot Number: 3495441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 01/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMITHS MEDICAL PORTEX TRACHEOSTOMY TUBE; SMITHS MEDICAL PORTEX TRACHEOSTOMY TUBE