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

Model Number 670170

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2019

Event Type  malfunction  

Event Description

Information was received indicating that the cuff to a smiths medical portex® bivona® tts¿ tracheostomy tube was found to be leaking.The pilot balloon was reported to be flattened and 3mls of water was remaining in the cuff.The was re-filled with 7mls of water but the pilot balloon was still flat.Water was removed from the cuff again with only 3mls remaining.A t-piece with oxygen concentrator was used that night and the trach tube was changed the next day.There were no reported adverse effects.

Manufacturer Narrative

Investigation completed on a smiths medical tracheostomy|silicone - bivona tubes adult tts.Two (2) pictures were received.In picture 1 one the original packaging from p/n 670170 l/n 3774411 is observed, in picture 2, one sample from p/n 670170 l/n 3774411 is observed inside the tray.Upon visual inspection on p/n 670170 l/n 3774411 a cut was found in the cuff.Functional testing on sample was done with 20 cc of air and when inflating the sample the cuff immediately deflated.When testing was done submerging under water the complaint was confirmed.Upon reviewing engineering process on production, all samples had passed 100 % prior to release of device.It is a theory that sharp edges may have compromised the device after removal of package and need for good visual inspection prior to placement along with testing device prior to inflating inside patient.After the audit, a sample was taken from scrap process of p/n 670170-sa l/n 3998095 and a small hole was done in the cuff using a pin.Then it was tested on leak test according to av-10006853 rev.101 leak testing and cuff symmetry visual aid.The complaint was confirmed.As preventive action production personnel were notified by quality engineer on 29/jun/2020 as awareness of the defect reported by the customer.

Event Description

Investigation completed on a smiths medical tracheostomy|silicone - bivona tubes adult tts summarized in h10.

• Brand Name: PORTEX BIVONA TTS TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9673898
• MDR Text Key: 177941335
• Report Number: 3012307300-2020-00675
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: 15021312006056
• Combination Product (y/n): N
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 670170
• Device Catalogue Number: 670170
• Device Lot Number: 3774411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 55