MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BLUE LINE ULTRA® SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/515/080

Device Problems Air Leak (1008); Hole In Material (1293); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2017

Event Type  malfunction  

Event Description

It was reported that around two days after intubation, an air leak from the cuff of a portex® blue line ultra® suctionaid tracheostomy tube occurred.No injury was reported.

Manufacturer Narrative

One suctionaid tracheostomy 8.0mm soft seal cuff.10/ca was returned for analysis in a used condition without the original packaging.The sample was visually inspected at a distance of 12" to 16" in normal conditions of illumination.No holes were detected.A syringe was used to inflate the cuff was performed and submerged under water in order to verify leaks revealing bubbles which is indicative of a leak.A review of relevant documents, manufacturing process, cuff assembly operation and inflation line assembly operation were performed.Inflation tests were audited during (b)(4) units in order to verify that the inflation tests were performed properly.A capa that was opened in 2016 was reviewed and show that the trend of cuff leakages downwards after actions performed, no further actions are necessary.The data will be monitored in the future customer complaints to detect any negative trend.The investigation show that trend of cuff leakages downwards after actions performed, no further actions are necessary and the capa will be closed.The complaint is confirmed as a cuff hole was found but the root cause is unknown.

• Brand Name: PORTEX® BLUE LINE ULTRA® SUCTIONAID TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6776945
• MDR Text Key: 82147197
• Report Number: 3012307300-2017-01728
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/515/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1