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

Catalog Number 60A180

Device Problems Material Frayed (1262); Material Too Rigid or Stiff (1544); Split (2537); Material Integrity Problem (2978)

Patient Problems Irritation (1941); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Event was first observed by the home care nurse on (b)(6) 2016.The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).

Event Description

It was reported that a portex® bivona® uncuffed adult tracheostomy tube end was starting to fray, had a "jagged" edge, and was splitting.The tracheostomy tube had been in use for 3 months and was removed and cleaned daily with a tracheostomy care kit and peroxide.The reporter noted that the tube appeared to be more stiff and brittle than tracheostomy tubes used in the past.The reported issues caused the patient discomfort and bleeding.No medication was administered but the patient's blood was being monitored for infection.No permanent injury was reported.

Manufacturer Narrative

One 8.0mm uncuffed tracheostomy tube was returned for investigation.Visual inspection was performed with the unaided eye, under normal manufacturing light conditions, and discoloration was observed on the posterior side of the shaft.Additionally, it was observed that the distal tip was chipped/jagged and there was a split/crack on the shaft on the anterior side of the shaft.The observed split/crack was approximately 7.5mm in length and approximately 5mm from the distal tip.No additional defects were identified.The molding device history record was reviewed for the shaft component and no anomalies were identified; all machine setup parameters were found to be within specification.The incoming inspection record for the raw materials was also reviewed and no anomalies were identified; all material requirements were within specification.The device instructions for use states that a tracheostomy tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days and that it may be reprocessed up to 10 times for a single patient reuse.Based on the details provide in the original complaint description, the device was reprocessed daily for three months which exceeded the number of reprocessing times specified in the instructions for use.The device was not validated to be reprocessed daily for three months (90 times).In addition, details provided in the complaint description state that peroxide was used to the clean the device.Peroxide is not a recommended cleaning agent listed in the instructions for use.The instructions for use state that only mild cleaning agents (e.G.Hand washing liquid) and hot water should be used for homecare cleaning/disinfection.The investigation determined that the device was manufactured per specification; however, excessive reprocessing contributed to the condition of the returned sample.

• Brand Name: PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBES
• 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: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6055457
• MDR Text Key: 58356626
• Report Number: 3012307300-2016-00193
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 60A180
• Device Lot Number: 3138296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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