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

Model Number	67PFS30
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A review of the device history records shows there were no observations recorded during manufacture suggest an issue of this nature would occur with this lot of product.A product sample was received for evaluation.Visual and functional testing were performed.One (1) sample was received without its original packaging inside a ziploc bag.Sample was received in used conditions, with its obturator and with its certificate of safe handling.Visual inspection was performed at 12 under normal lighting to received unit, in order to detect any damage on the cuff.During the visual inspection, black spots were found in the tube.The unit as inflated with 5 cubic centimeter of air in order to see if there was any functional problem.When inflating the unit with air, the cuff inflated without problems.A review of the manufacturing process for part and list number, was conducted by quality engineer in order to verify that there are no situations or practices that could create the event as described in description of non-conformance section.All procedures are being carried appropriate.During the verification, 32 assemblies were reviewed to see if they had a molding issue such as short shot, cuts, split, voids, bubble or contamination according to procedures, no damage was detected on the units.The root cause of the reported issue could not be confirmed during evaluation; however, the most probable root cause is that damage occurred after the device left the manufacturing site.As a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.
Event or Problem Description
It was reported that the cuff of the canula is defective after 2 sterilization (vs 5 sterilization recommended by the manufacturer).Customer requires a replacement or credit.No patient injury was reported.

• 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: 15624908
• Report Number: 3012307300-2022-24789
• Device Sequence Number: 6184123
• Product Code: JOH
• UDI-Device Identifier: 10351688518606
• UDI-Public: 10351688518606
• Combination Product (Y/N): N
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: 08/29/2023
• Device Model Number: 67PFS30
• Device Catalogue Number: 67PFS30
• Device Lot Number: 3692737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Is the Reporter a Health Professional?: Yes
• 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: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2018
• 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 Age: 4 MO
• Patient Sex: Male
• Patient Weight: 3 KG