MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. BIVONA AIRE-CUFF NEONATAL & PEDIATRIC TRACHEOSTOMY TUBES

Catalog Number 65P045

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

A report was received stating that the device was observed leaking at the cuff.After 2 hours of use, there was no remaining pressure in the cuff.No incident related medical sequela was reported.

Manufacturer Narrative

One used sample returned for evaluation.Simulated use testing was performed by inflating the cuff with 6 cc of air and leak tested.No leaks were detected.Unable to reproduce the reported issue.No fault found.

• Brand Name: BIVONA AIRE-CUFF NEONATAL & PEDIATRIC TRACHEOSTOMY TUBES
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; gary IN
• Manufacturer (Section G): SMITHS MEDICAL MD, INC.; 5700 west 23rd ave.; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5018652
• MDR Text Key: 23723707
• Report Number: 2183502-2015-00574
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K914088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 65P045
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2015
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1