MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BIVONA® UNCUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 60P040

Device Problem Break (1069)

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

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

Report source:(b)(6).

Event Description

Information was received indicating that nine days following cannula change out to a smiths medical portex® bivona® uncuffed tracheostomy tube a breakage to the flange was noted.Subsequently, a tube change out was required with no reported adverse patient effects.

Manufacturer Narrative

One tracheostomy was returned for evaluation.Visual inspection found the device to have two splits on the flange eyelet.Device underwent testing by making a small cut in a neckflange eyelet with a blade into two pieces.As a result, the customer complaint was confirmed.The most probable root cause is that damaged occurred after the product left the shm facility.

• Brand Name: PORTEX® BIVONA® UNCUFFED TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 8073731
• MDR Text Key: 127244142
• Report Number: 3012307300-2018-08188
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312005752
• UDI-Public: 15021312005752
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 60P040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 01/10/2019
• 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
• Patient Outcome(s): Required Intervention