MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/897/080

Device Problems Decrease in Pressure (1490); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received that a smiths medical portex uniperc adjustable flange tracheostomy tube had problems with the cuff holding pressure while in use with a patient.Twenty days after incretion, the tracheostomy (trach) tube was replaced with another smiths medical portex trach.Following the change out, it was discovered the initial trach pilot balloon and cuff appeared to be full of "water, fluid, and/or secretions." no adverse patient effects were reported.

Manufacturer Narrative

One portex uniperc tracheostomy (trach) tube was returned for analysis in used conditions.Under visual inspection the trach tube appeared to be in good condition, no water / fluid was found in the pilot balloon and no tear in the cuff was noted.Inflation test was performed; no discrepancies found.Based on the evidence there was no fault found for the root cause as the complaint was not confirmed.

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8011148
• MDR Text Key: 125271334
• Report Number: 3012307300-2018-01930
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: 15019315060441
• Combination Product (y/n): N
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/897/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR