MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ENDOTRACHEAL TUBES SILICONIZED; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/166/0651
Medical Device Problem Codes	Air Leak (1008); Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer inserted the product into the patient at night.The next morning, they noticed air leakage from it.Upon checking it, they found a pinhole in it and stopped using it.No death or serious injury was reported in connection with this incident.
Event or Problem Description
Additional information received indicates a tracheostomy tube change out was successfully performed due to the leaking cuff.No patient injury.
Additional Manufacturer Narrative
One portex® soft seal® cuff tracheal tube was returned for analysis in used condition.No discrepancies were found upon visual examination.The product was submerged under water while attempting to be inflated; noting leakage coming from a small tear in the cuff.Relevant documents were reviewed and deemed adequate.An audit was performed of a section of the production floor observing no discrepancies with training records and personnel were following procedure tracheal manual flow line - bell-out, fit inflation line and leak test.No discrepancies were found during review of (b)(4) samples from manufacturing process.Based on the evidence, the complaint was confirmed.However, the root cause is unknown at this time.

• Brand Name: PORTEX ENDOTRACHEAL TUBES SILICONIZED
• 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: 7611363
• Report Number: 3012307300-2018-02425
• Device Sequence Number: 13486388
• Product Code: BTR
• UDI-Device Identifier: 15019315054075
• UDI-Public: 15019315054075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 100/166/0651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 06/14/2018; 09/03/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 06/22/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention