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

Model Number	67NFPS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes neo/ped flextend cuffs were not inflating when tested.The report by a nurse stated the baby was having respiratory status worsening with feeding and oxygen needed to be increased with patient suctioned and percussed supine and prone.Rtt was summoned and a trach change was done, after four times trying the patient required atrovent extra dose with report of patient resting comfortable after intervention.
Event or Problem Description
Device evaluation completed and summary in h 10.
Event or Problem Description
Device evaluation completed and summary in h 10.
Additional Manufacturer Narrative
This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Three (3) samples were received in used conditions, with their original lid and with their certificate of decontamination.Functional test: samples were filled with 5 cubic centimeter (cc) of air according to procedures to see if there was any functional problem.Results: when the samples were inflated with air, the pilot balloon inflated but all the air was stuck it.According to the instruction for use the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely and symmetrically.The complaint was not confirmed.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.Root cause could not be determined since the sample successfully passed functional test.No corrective actions were taken since the complaint was not confirmed, corrected data: corrected d1 d2 g1 h1 h3.

• 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: 12009343
• Report Number: 3012307300-2021-06108
• Device Sequence Number: 4482442
• Product Code: JOH
• UDI-Device Identifier: 10351688518781
• UDI-Public: 10351688518781
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2023

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: Health Professional
• Device Expiration Date: 01/06/2026
• Device Model Number: 67NFPS30
• Device Catalogue Number: 67NFPS30
• Device Lot Number: 4095914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/25/2021; 07/25/2021; 01/31/2023
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/24/2021; 08/25/2021; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown