MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60NFPS35
Medical Device Problem Codes	Crack (1135); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ten samples (4 from p/n 60pfss40, five from p/n 60pfss45 and one from p/n unknown) were returned for analysis; all in used conditions.The flanges were observed to be broken and with splits were noted upon visual inspection.No discrepancies were found with review of the manufacturing and assembly process.Verification of 32 units was performed; observing no damage.Based on the evidence the complaint was confirmed but the root cause is unknown.The most probable root cause is that damage occurred after the product left the manufacturing facility.
Event or Problem Description
Information was received indicating that the flange to a smiths medical bivona flextend¿ tts¿ tracheostomy tube was found to be cracked and separated from the tube.The trach tube was changed out and returned for investigation.There were no reported adverse patient effects.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8856931
• Report Number: 3012307300-2019-03958
• Device Sequence Number: 11445758
• Product Code: JOH
• UDI-Device Identifier: 15021312516692
• UDI-Public: 15021312516692
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60NFPS35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/02/2019
• 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