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

Model Number	FU22JN40NGF096N
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported the template for 2 custom trachs is for the shaft to be 49mm.The customer said this is not correct and the shaft is too short.She has an older trach that is a 49mm shaft and was having problems with the flange at that time being too short.Now the flange is correct, but the shaft is too short.The shaft length is shorter than the specified 49mm.Additional information received on (b)(6) 2022 via email and attached to complaint object: customer reported that it was prior to placing the device with the patient compared with old one.No injury and no medical intervention were reported.The outcome of the event was ongoing and need a corrected replacement done.Updated event details.Updated patient details.
Additional Manufacturer Narrative
Device evaluation was done of the returned device.Visual inspection showed no anomalies.Comparing the device to the template, all the measurements and the device matched all the requested stipulations.The devices are allowed margins of error.Investigators went over the last requested custom devices and found that the current one was within the same specifications as the one that was complained on.Due to this, no device fault was found.The complaint could not be confirmed.No corrective actions taken at this time.Device history review shows no non-conformities, during the manufacturing process.

• Brand Name: SILICONE - BIVONA TUBES CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16121449
• Report Number: 3012307300-2023-00242
• Device Sequence Number: 8396508
• Product Code: JOH
• UDI-Device Identifier: 15019517320176
• UDI-Public: 15019517320176
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: Lay User/Patient
• Device Model Number: FU22JN40NGF096N
• Device Catalogue Number: FU22JN40NGF096N
• Device Lot Number: GB001253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown