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

Catalog Number 100/870/080

Device Problems Leak/Splash (1354); Material Perforation (2205)

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

Event Date 05/07/2016

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that a portex® blue line ultra® suctionaid tracheostomy tube inner cannula had a leak.It was noted that there were micro-perforations in the cuff.The issue was observed after less than one month of use and had been "exchanged in" three times.No patient injury was reported.

Manufacturer Narrative

Device evaluation in progress the device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was further reported that the device was in patient use when the reported event occurred.According to the report, "on 30/4/2016 and 07/05/2016, it was realized test with cuffometer monitoring was performed.We identified that they had the perforated balloon." it was reported that the patient received medical treatment and "realized changed of cannulas in residence and in hospital ready care, due respiratory instability." the patient was clinically stable "after changes" and the issue was resolved.No medical intervention occurred and no patient or clinical injury occurred.The reported device was in patient use for seven months prior to the reported event.The device was tested prior to patient use.

Event Description

It was further reported that the event occurred with two different devices.According to the reporter, the patient went from residence care to hospital care.Related mfr #: 3012307300-2017-00749.

Manufacturer Narrative

Two tracheostomy tubes were returned for evaluation in used condition and without original packaging.Visual inspection of the devices found no discrepancies.Functional testing involved a leak test and showed a leak at the pilot balloon in one of the two devices.A review of the testing and inspection documents was conducted and deemed adequate.A review of the manufacturing process of a similar lot was conducted and did not find any discrepancies.Functional testing involved 32 similar devices in an inflation test and no deflated pilot balloons were detected.Based on the evidence, the root cause of the reported issue was attributed to a manufacturing issue.The most probable root causes are related to the blow molding process, wear of the coating and stamping, and the undetected leak on the pilot balloon.

• Brand Name: PORTEX® BLUE LINE ULTRA® SUCTIONAID TRACHEOSTOMY TUBE INNER CANNULA
• 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, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6167409
• MDR Text Key: 62158109
• Report Number: 3012307300-2016-00554
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 100/870/080
• Device Lot Number: 3021547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 97