MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES NEO/PED FLEXTEND PLUS; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60PFS50
Medical Device Problem Codes	Gel Leak (1267); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the caretaker, heard an audible leak, followed by an alarm from the ventilator.The caretaker immediately removed the faulty trach tube and inserted a new one, on the ventilator dependent child.It was revealed that the silicone on the faulty tube had a split at the top of the shaft, exposing the coiled wire.The trach tube had only been used twice at this point.No further complications were reported in connection with this incident.
Additional Manufacturer Narrative
One used sample received without original packaging.Upon visual inspection, sample was observed to have a split on the shaft.32 assemblies were reviewed to see if they had a molding issue such as "short shot, cuts, split, voids or bubble" and to verify it doesn't contain exposed wire at shaft, no damage was detected on the units.The most probable root cause is that damaged occurred after the product left the shm facility.

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND PLUS
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7891752
• Report Number: 3012307300-2018-03745
• Device Sequence Number: 11239858
• Product Code: JOH
• UDI-Device Identifier: 15021312005882
• UDI-Public: 15021312005882
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 60PFS50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention