MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 670175

Device Problems Material Discolored (1170); Fluid/Blood Leak (1250); Cut In Material (2454)

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

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

Potential lot numbers - 3117359 and 3129407, additional 510(k) - k083641.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that the cuff of a portex® bivona® adult tts¿ tracheostomy tube leaked after 20 days in use.Cuff patency had been tested prior to use.The tracheostomy tube had been reprocessed twice with boiled water prior to the event.Sterile water was used to fill the cuff.Hospital personnel noticed the issue after the ventilator alarmed.Once the leak was found, the tracheostomy tube was replaced.No injury was reported, however, the outcome of the event was reported to be ongoing.

Manufacturer Narrative

Smiths medical received one 7.5 mm portex® bivona® adult tts¿ tracheostomy tube for analysis.Discoloration of the tracheostomy (trach) tube was noted upon visual inspection.Inflation test was performed using a standard syringe; 16 cc of air was inserted into the inflation line with no noted cuff inflation.A leak coming from the cuff was observed while performing a system leak test.A cut, 1 mm in length, was noted in the cuff at that time.Instructions for use reviewed which states not to come into contact with sharp objects.Manufacturing procedures reviewed which reflects that quality performs a sample leak test on the devices prior to packaging.Based on the evidence, the investigation did not determine a manufacturing defect.No corrective actions are required at this time.

• Brand Name: PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6634864
• MDR Text Key: 77434700
• Report Number: 3012307300-2017-01244
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: 15021312006063
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K944178
• 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
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 670175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Weight: 85