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

Catalog Number	60NFP40
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k): k083641.
Event or Problem Description
It was reported that the airway adapter could not be separated from the neonatal/pediatric tracheostomy tube.No serious injury was reported in connection with this incident.The patient was however manually "bagged" while the airway adapter was removed from the tracheostomy tube assembly.
Additional Manufacturer Narrative
Two samples were received for analysis: one from p/n 007/782/035 and the other from: p/n 007/782/030 both samples were connected to an unknown product.The units are in used conditions without their original packaging.Samples were visually inspected, at a distance of 12" to 16" and normal conditions of illumination.During the visual inspection, it was noted that the 15mm connectors were attached to an unknown product.Functional testing included use testing was performed.During investigation an attempt was made to separate the connector from the unknown product and it was very easy to separate the connectors with both samples.Additional samples were connected again to the unknown product and they were separated using a disconnecting wedge, once the wedge was inserted, the connectors were separated easily without applying any force.The diameter of the connectors was inspected, and no discrepancies were found.Based on the evidence, the complaint was unable to be confirmed.As a preventive action production personnel were notified by quality intern to awareness of the defect reported by the customer.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
• 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: 7474073
• Report Number: 3012307300-2018-03125
• Device Sequence Number: 16447996
• Product Code: JOH
• UDI-Device Identifier: 15021312014747
• UDI-Public: 15021312014747
• Combination Product (Y/N): N
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: No Information
• Device Expiration Date: 01/12/2022
• Device Catalogue Number: 60NFP40
• Device Lot Number: 3332238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THE PHILIPS M2772A AND M2773A ADAPTERS; THE PHILIPS M2772A AND M2773A ADAPTERS
• Outcome Attributed to Adverse Event: Required Intervention