MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE AND CUFF

Model Number	60PFSS45
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a smiths medical trach tube got dislodge this time.No adverse patient effects were reported.
Event or Problem Description
Investigation completed and no product was returned, however a picture of device torn was.H 10 engineering summary of analysis.
Additional Manufacturer Narrative
Other text: investigation completed on a smiths medical tracheostomy | silicone - bivona tubes neo / ped flextend plus.Picture was received, which observed a split on the corner of the flange.According to pfmea 10018858-001 rev.100 - ifu-flextend tracheostomy the occurrence for broken neckstrap condition could be caused by: supplier process related.Instructions for use were reviewed? 10018858-001 rev.100 - ifu-flextend tracheostomy? on section 4.8 states? guard against product damage by avoiding contact with sharp edges.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity.A damaged eyelet can result in decannulation of the tracheostomy tube.We recommend using the twill tape holder supplied with the product.? engineering and occurrence reviewed which performed 100% prior to release of product.No corrective actions were taken.However, as part of containment, production personnel was notified by quality engineer on 13/nov/2020 as awareness of the defect reported by the customer.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10834466
• Report Number: 3012307300-2020-11423
• Device Sequence Number: 4142206
• Product Code: JOH
• UDI-Device Identifier: 15021312516791
• UDI-Public: 15021312516791
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 60PFSS45
• Device Catalogue Number: 60PFSS45
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/15/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1