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

Model Number	67PFS35
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2019
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 certificate of decontamination.Visual inspection was performed at 12 under normal lighting to received unit, in order to detect any damage on the cuff or airline.No discrepancies were found.The sample was tested on leak test.The test was performed under water as per procedure.During the test, a leak was found on the cuff the most probable root causes are: the unit was damaged during the use of the tweezers after cleaning and before to packaging.The unit was damaged after the product left the shm facility.The following actions were taken: production personnel was re-trained on by the area trainer.The purpose of the training was re-forced the note on the procedure, which states the following: for cuff products only: after cleaning and before packaging, if the piece needs to be rework , the unit has to be tested to make sure that is not affected?.The training was completed.Production personnel was re-trained by the area trainer in order to indicate the steps to perform during the 100% leak test of the units.The training was completed.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 during pre-test, the cuff could not be inflated.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: 15625358
• Report Number: 3012307300-2022-24826
• Device Sequence Number: 14998470
• Product Code: JOH
• UDI-Device Identifier: 10351688518613
• UDI-Public: 10351688518613
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• 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: 11/10/2023
• Device Model Number: 67PFS35
• Device Catalogue Number: 67PFS35
• Device Lot Number: 3727252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• 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: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2018
• 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 Sex: Unknown