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

Model Number	FT16BN60NGF038N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the trach tube cuff would not inflate.Two lot numbers were reported.No patient injury was reported.The first lot number was previously reported on medwatch number 3012307300-2022-27181.Further details have been requested to determine if there were two items used in this incident or if the first lot number was only faulty on (b)(6) 2022.
Additional Manufacturer Narrative
Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection under normal plant lighting and by the unaided eye did not reveal any defects with the two returned devices.Using a syringe, 10 cc of air was inserted into the inflation valve.The cuffs fully inflated.The instruction for use (ifu), states "if the cuff does not inflate completely, squeeze the pilot balloon while gently manipulating the cuff from the shaft".Since both cuffs immediately inflated, actions identified in the ifu were not performed.The devices were leak tested per work instruction.No leaks were detected.The reported problem of the cuffs not inflating could not be confirmed.The devices were allowed to rest for 5 days and retested by inserting 10 cc of air into the inflation valve.The cuffs fully inflated.The investigation did not identify a manufacturing defect with the returned devices.No device problem was found.No corrective actions are planned at this time.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.

• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15905732
• Report Number: 3012307300-2022-27713
• Device Sequence Number: 5126481
• Product Code: JOH
• UDI-Device Identifier: 15019517040531
• UDI-Public: 15019517040531
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: FT16BN60NGF038N
• Device Catalogue Number: FT16BN60NGF038N
• Device Lot Number: GA029054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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