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

Model Number	67PFPS50
Medical Device Problem Codes	Defective Component (2292); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon pre-test, the trach was malfunctioning.No further information was known, as distributor reported this through client.No patient injury was reported.
Additional Manufacturer Narrative
Mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.One (1) sample was received without its original packaging inside a ziploc bag.Visual inspection was performed at 12 under normal conditions of illumination in order to detect any damage on the part.No damage could be detected.Sample was inflated with 5 cubic centimeter (cc) of air in order to see if there was any problem with the unit.When inflating the unit, it was seen that a part wasn't inflated uniformly.Stretch marks were found in cuff.According to the information for use, the cuff was manipulated and the whole cuff inflated.During the manipulation, the cuff was peeled off from the part where the stretch marks were found.The root cause for the reported issue was found to be excess of parylene in the unit.The following actions were taken.Per previous complaints, as correctly actions, 6 quartz where purchased to have a backup and to make sure they had the time to clean them well.Per previous complaint, procedure was being updated from revision 100 to revision 101 in order to include as part of the cleaning of the superslick, the cleaning of the rack that support the delring fixtures to prevent particulates on pieces.Changed was initiated.Per previous complaint, as mitigation an alert was generated to ensure that racks has to be clean of parylene fibers to avoid contaminations on the units.?as preventive action, production personnel was notified by area trainer as awareness of the defect reported by the customer.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: 15591510
• Report Number: 3012307300-2022-23595
• Device Sequence Number: 2236566
• Product Code: JOH
• UDI-Device Identifier: 10351688518569
• UDI-Public: 10351688518569
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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 Expiration Date: 06/15/2022
• Device Model Number: 67PFPS50
• Device Catalogue Number: 67PFPS50
• Device Lot Number: 3450317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2017
• 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