MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PEDIATRIC TRACHEOSTOMY TUBE 6.0 TTS FLEXTEND PLUS STRAIGHT FLANGE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 67PFPS606

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2018

Event Type  malfunction  

Event Description

It was reported that the bivona trach tube developed a leak while in use with the patient.No death or serious injury was reported in connection with this incident.

• Brand Name: PEDIATRIC TRACHEOSTOMY TUBE 6.0 TTS FLEXTEND PLUS STRAIGHT FLANGE
• 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 MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7824222
• MDR Text Key: 118483387
• Report Number: 3012307300-2018-03469
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 67PFPS606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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