MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA® UNCUFFED NEONATAL & PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 60NFP40

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Respiratory Distress (2045); Ventilator Dependent (2395); Extubate (2402)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a patient while on a bivona® uncuffed neonatal and pediatric flextend¿ plus silicone tracheostomy tube, she experienced a broken flange and decannulation.Information was received on the (b)(6) 2016, which stated that a nurse informed a senior member on the team that she had noticed that the flange area was torn during the routine daily tie change.An unexpected, but safe tube change was carried out with a pediatric 4.0.The other boxes of tracheostomy tubes were checked and an alert from the manufacturer stated not to use the "velcro" tapes as the material was sharp and can cut the flange.The customer was unaware of this; however, at the time the patient was using the cotton twill ties indicated for the correct product.The following day ((b)(6) 2016), the emergency buzzer was pulled as the child had become profoundly desaturated and was in respiratory distress.The tracheostomy tube (second event) had come out (decannulated); this was placed back in and then an emergency tube change was performed.When the tube was removed, the flange was found to be completely torn.This event occurred while the patient was on a neonatal 4.0.At the time of event, the patient required ventilator support.The event resolved with time, by further requirement of oxygen support and an x-ray.The patient had a regular medical review and a rest day in terms of trailing on dry circuit.Mfr report number 3012307300-2017-00039 for the related event.

Manufacturer Narrative

One 4.0mm bivona® uncuffed neonatal and pediatric flextend¿ plus silicone tracheostomy tube was returned for investigation.A review of the device history log, for the reported lot, was found to be complete.Visual inspection of the returned device found that one of the neck flange eyelets was completely torn.Magnification examination of the tear found a partial tear near the observed complete tear.The tears were found in the area where the securing tape contacts the neck flange.Investigation was unable to definitely determine the root cause of the observed tears; however, no evidence was found to suggest a manufacturing defect.

• Brand Name: BIVONA® UNCUFFED NEONATAL & PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE
• 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 ; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6247699
• MDR Text Key: 64712626
• Report Number: 3012307300-2017-00040
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: 60NFP40
• Device Lot Number: 2753235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• 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
• Treatment: PEG FED; VENTILATOR WITH 25% O2
• Patient Outcome(s): Required Intervention
• Patient Age: 8 MO