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

Model Number	60PFSS30
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, expiration date and manufacture date are unknown, in information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the customer have had 2 incidents of split flanges on the tracheostomy tubes.Occurred while in use with patient, a trach tube was required.No patient injury reported.(b)(4) documents that first product malfunction and (b)(4) documents the second product malfunction.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.Two device samples were received in used condition without the original packaging.Per visual inspection, it was detected a cut in the flange/neck strap.The complaint was confirmed.No other analysis was performed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The cause for the condition was due to manufacturing.The complaint fault has been escalated to address a full root cause investigation for damaged flange/neck strap issues and is currently in the investigation phase.

• Brand Name: BIVONA ADULT TIGHT TO SHAFT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16746926
• Report Number: 3012307300-2023-04172
• Device Sequence Number: 19649527
• Product Code: JOH
• UDI-Device Identifier: 15021312516760
• UDI-Public: 15021312516760
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Model Number: 60PFSS30
• Device Catalogue Number: 60PFSS30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown