MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67P045
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer had an issue with the tracheostomy tubes on one of their pediatric patients.The patient did have an issue with desaturation and their tracheostomy tube needed to be changed out.Additional information received via customer response email dated 01-jul-2022: the cuff did not seal with placement of sterile water, large leak noted, decompensation.Nurse was called to bedside, could hear infant crying with decompensation, added 1 cc of sterile water and there was no effect, changed out to another size tracheotomy tube.Prematurely needed to change tracheostomy tube until we had a good seal with cuff and no leak and no decompensation, good bilateral breath sounds.
Event or Problem Description
Additional information was received which included patient age, race, sex, ethnicity and weight.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: update not required additional patient information received (updated a2,a3, a4, a5, a6, b5) e4 is unknown, no information provided to date.A product sample was received and is awaiting evaluation and investigation 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.
Additional Manufacturer Narrative
H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
• 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: 15117197
• Report Number: 3012307300-2022-14376
• Device Sequence Number: 6603875
• Product Code: JOH
• UDI-Device Identifier: 15021312006285
• UDI-Public: 15021312006285
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• 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,Followup,Followup
• Report Date (Section B): 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 67P045
• Device Catalogue Number: 67P045
• Device Lot Number: 4216302
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 10/04/2022; 06/15/2023
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 12/06/2022; 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 MO
• Patient Sex: Female
• Patient Weight: 12 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White