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

Model Number	67PFS40
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient received two trach tubes, both of which would not hold air.No patient injury was reported.
Additional Manufacturer Narrative
One (1) sample was received in its original packaging inside a ziploc bag, in used conditions and without its certificate of decontamination.Visual inspection was performed at 12 in under normal lighting to received unit, in order to detect any damage on the cuff, airline or pilot balloon.No damaged was detected.Functional test: sample was filled with 5cc of air in order to see if there was any functional problem.After the whole cuff inflated, the device deflated and inflated 4 times, and at all times the cuff inflated completely.The complaint was not confirmed.The sample was tested on leak test and no leak was detected.A device history record (dhr) review was not performed as no lot or serial numbers were provided.If the product is returned, this complaint will be reopened for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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: 15410903
• Report Number: 3012307300-2022-18946
• Device Sequence Number: 14862930
• Product Code: JOH
• UDI-Device Identifier: 10351688518620
• UDI-Public: 10351688518620
• 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: User Facility
• 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 Model Number: 67PFS40
• Device Catalogue Number: 67PFS40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• 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
• 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