MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA BLUPERC PERCUTANEOUS DILATION PROCEDURAL KI; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	65P050
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for investigation.The iso taper test was performed to the 15mm connector according to our quality procedures.During the test the connector was not within the acceptable range and did not pass the test.The complaint was confirmed, and it was determined the component was received out of specification from the supplier.No lot number was provided, so no dhr was able to be done.During the manufacture process though, each device is checked per quality standards.We have reached out to the supplier for explanation on the quality control deficiency.
Event or Problem Description
It was reported that during the use of the product, the customer connected a filter to the trach tube, using a strong force.The diameter of the product was a little larger than normal making the connection not fitting all the way.The product was indwelled in the patient for about 30 days.No patient injury was reported.

• Brand Name: BIVONA BLUPERC PERCUTANEOUS DILATION PROCEDURAL KI
• 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; 2-3-2 kamiochiai, chuoh-ku,; minneapolis, MN 55442
• MDR Report Key: 13446860
• Report Number: 3012307300-2022-02499
• Device Sequence Number: 4305204
• Product Code: JOH
• UDI-Device Identifier: 15021312005998
• UDI-Public: 15021312005998
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083641
• 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
• Report Date (Section B): 02/03/2022

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: 65P050
• Device Catalogue Number: 65P050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian