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); Tear, Rip or Hole in Device Packaging (2385); Physical Property Issue (3008)

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

Event Date 07/09/2017

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.

Event Description

It was reported that four days after intubation, a portex® blue line ultra® suction aid tracheostomy tube leaked air.Several attempts were made to fill the cuff with air, but the cuff would not inflate.The tracheostomy tube was extubated and more attempts were made to fill it with air, but the attempts failed.A close look at the cuff revealed a damage to it.No injury was reported.

Manufacturer Narrative

One suctionaid tracheostomy 8.0mm soft seal cuff.10/ca was returned for analysis in a used condition and without its original packaging.Visual inspection was performed at 12'' to 16'' with normal conditions of illumination revealing no holes.However, upon inflation of the cuff the sample revealed several long tears (2 mm in length) along with inability to maintain cuff pressure.To verify for leaks, a syringe was used to inflate the submerged cuff; detecting bubbles.Inflation tests were audited in 32 units to verify that the inflation test was properly performed.No deflated cuffs were detected.Documents and the manufacturing process were reviewed to verify that no situations or practices could create the complaint that was reported.Cuff assembly and inflation line assembly operations were reviewed to verify that the operations were properly performed.No discrepancies were found.Based on the evidence, the complaint was confirmed and 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: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6751783
• MDR Text Key: 81323226
• Report Number: 3012307300-2017-01603
• 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: foreign,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/515/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 11/23/2017
• Supplement Dates FDA Received: 12/04/2017
• 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