MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SILICONE - BIVONA TUBES NEO/PED; 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	06/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Three pictures and a sample were received for evaluation.It was observed, the flange is completely broken, the cut shape is irregular and there is contamination on it.Sample was received in used condition without its original packaging.During visual inspection under normal conditions of illumination, it was observed that the flange was found broken.A retrospective review for the complaints related to the showed there was no trend associated to this failure of broken flange.During functional analysis, the failure mode could not be reproduced during the molding process since the cut created is not in the same position as sample received, the reproduced cut is deeper than cut from sample received.Based on the tests performed to replicate the failure mode, where it could not be reproduced, the most probable root cause is that damage occurred after manufacturing.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.
Event or Problem Description
It was reported that while the trach was in place, a snapping sound was heard.It was observed that the flange got damaged.They would like to know why this issue happened.No patient injury reported.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).

• Brand Name: SILICONE - BIVONA TUBES NEO/PED
• 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: 16869276
• Report Number: 3012307300-2023-05068
• Device Sequence Number: 17593887
• Product Code: JOH
• UDI-Device Identifier: 15021312000382
• UDI-Public: 15021312000382
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/05/2023

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: Health Professional
• Device Model Number: 60SP040
• Device Catalogue Number: 60SP040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 05/05/2023
• 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 Sex: Unknown