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

Model Number	67PFS50
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after going through an operation, the customer attempted to connect the product to a third party's medical fluid infuser, but they were unable to be locked with each other firmly.No patient injury reported.
Additional Manufacturer Narrative
During observation of the flat filter, whitening was confirmed at the root of the lug on the female connector.Next, to check the function, we have connected an iso80369-6 inspection gauge and confirmed that the connection is possible without any abnormalities.Also, when water was injected with a syringe, no leakage was observed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15403323
• Report Number: 3012307300-2022-18753
• Device Sequence Number: 6179073
• Product Code: JOH
• UDI-Device Identifier: 10351688518644
• UDI-Public: 10351688518644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: 67PFS50
• Device Catalogue Number: 67PFS50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 09/12/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown