MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	60PFS35
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	04/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
Event or Problem Description
It was reported that a bivona trach tube has split.The customer noticed a split at the end of the tracheostomy tube (where you connect the swedish nose or ventilator tubing).An emergency trach change was performed.Lot number is not known.No other information was provided.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.Device evaluation: two samples were received in used conditions without the original package.Samples were visually inspected under normal conditions of illumination.Cut was found in two samples, complaint was confirmed.Root cause: based on the analysis conducted in the sample provided, failure mode was confirmed.Therefore, the occurrence of this failure condition could be caused by mishandling during unload.Action taken: customer complaint notification was made to production personnel to explain the importance to adherence or following in the manufacturing procedure, by quality engineer on 11/jan/2023.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14517220
• Report Number: 3012307300-2022-09756
• Device Sequence Number: 6429000
• Product Code: JOH
• UDI-Device Identifier: 15021312005851
• UDI-Public: 15021312005851
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: Other
• Device Model Number: 60PFS35
• Device Catalogue Number: 60PFS35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 05/11/2023
• 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