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

Model Number	67NFPS35
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Six (6) samples were received from various lot numbers.All samples were in used conditions, inside their opened original packaging.During the visual inspection, the following was observed: an unknown substance was found on the shaft from sample 3, neckstrap from sample 5 was discolored and two splits were observed on the cuff from sample 5.Samples were filled with air in order to see if there was any functional problem.When inflating the sample 1,2,3,4 and 6 with air, it was seen that cuff was not uniformly.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.When inflating the sample 5 with air, the cuff immediately deflated.The samples were tested on leak test.When the sample 5 was tested, a leak was found on the cuff.Finally, samples 1,2,3,4 or 6 were filled were filled with 5cc of water in order to detect any leak.No leaks were detected during the test.A review of the manufacturing process was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause is that damaged occurred after the product left the manufacturing facility.As a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that during pre-test, the cuffs failed to inflate.No patient injury reported.

• Brand Name: BIVONA TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY
• 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; minneapolis, MN 55442
• MDR Report Key: 15635773
• Report Number: 3012307300-2022-25218
• Device Sequence Number: 2748605
• Product Code: JOH
• UDI-Device Identifier: 10351688518798
• UDI-Public: 10351688518798
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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: 67NFPS35
• Device Catalogue Number: 67NFPS35
• Device Lot Number: 3760474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/19/2022
• 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