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

Model Number	67PFS40
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were white and brown stains on the cuff after sterilization.Before sterilization, the tube was washed with mild soap and water.The tube was unusable and another one was used.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.The sample was received in used conditions, with its certificate of safe handling and without its original packaging inside a ziploc bag.Visual inspection was performed at 12" under normal lighting to received unit, in order to detect any damage on the cuff or airline.Results: during the visual inspection, we observed yellow stains in the cuff.Contamination not well measured for this occurrence the mitigation to detect the reported complaint.Components are 100% inspected by production personnel before and after every operation to detect any contamination.If during the inspection, they detect contamination in the parts, it is measured to ensure that meet with the specification of finished goods.Components are 100 percent inspected by production personnel before and after every operation to detect any contamination in the units.Quality inspectors takes a representative sample of the lot and performs a visual inspection in order to detect any contamination on the units according to inspection for finished goods.The most probable root cause is that damaged occurred after the product left the facility.No corrective actions were taken.No information has been provided to date.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; minneapolis, MN 55442
• MDR Report Key: 15414726
• Report Number: 3012307300-2022-19019
• Device Sequence Number: 5512380
• Product Code: JOH
• UDI-Device Identifier: 10351688518620
• UDI-Public: 10351688518620
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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 Expiration Date: 02/19/2024
• Device Model Number: 67PFS40
• Device Catalogue Number: 67PFS40
• Device Lot Number: 3735240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown