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

Model Number	60SP040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tracheostomy tube was secured in the tracheal stoma of the patient when the left flange broke at the securing part and resulted in the tracheostomy tube decannulating.No patient injury was reported.
Additional Manufacturer Narrative
Operator of device was patient.
Additional Manufacturer Narrative
Other text: no product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.No lot number was provided for device history record review.D5 is the patient/consumer.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: three samples was returned for investigation.The samples were received without its original packaging, decontaminated and inside in a plastic bag.The sample was visually inspected under normal conditions of illumination to detect conditions that could cause functional issues.Sample one was observed to have the right eyelet broken, as if it had been cut with a sharp instrument.Sample two did not present any damages or discrepancies.Sample three was observed to have the right eyelet broken, as if it had been cut with a sharp instrument.Per the physical evaluation of the samples, the reported failure mode was confirmed.Per the investigation, the most probable root cause is that the cut damaged on the cuff occurred after the product left the facility.No corrective actions were required because the mitigations in place were revised and executed as determined by procedure.This failure will continue to be monitored to determine if new actions need to be taken.The root cause was unknown/undetermined.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: correction: no lot/serial number was provided, therefore the product manufacture or expiration date was unknown.

• Brand Name: BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; marlborough road; minneapolis, MN 55442
• MDR Report Key: 14688912
• Report Number: 3012307300-2022-11761
• Device Sequence Number: 12421421
• Product Code: JOH
• UDI-Device Identifier: 15021312000382
• UDI-Public: 15021312000382
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2023

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: 60SP040
• Device Catalogue Number: 60SP040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 09/12/2022; 04/10/2023
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 10/11/2022; 05/12/2023
• 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
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Race: White