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

Catalog Number	67N035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: 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.
Event or Problem Description
It was reported that the cuff of the trach tube was not inflating appropriately.Despite massaging of balloon and cuff itself, only a portion of it was inflating.This was checked prior to a scheduled trach change; so caught beforehand and another tube was used.Patient therefore unaffected and not involved.Product is returning for investigation.
Additional Manufacturer Narrative
Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received in used condition without the original packaging.Per functional test: sample was filled with 5cc of air, then the cuff was measured for symmetry.The result was out of specification.The complaint was confirmed.A root cause for the condition could not be determined.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will be monitored, and further actions taken accordingly.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17647580
• Report Number: 3012307300-2023-08515
• Device Sequence Number: 15257091
• Product Code: JOH
• UDI-Device Identifier: 15021312006223
• UDI-Public: 15021312006223
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944178
• 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
• Report Date (Section B): 10/26/2023

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: 03/27/2024
• Device Catalogue Number: 67N035
• Device Lot Number: 3775441
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/23/2023
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• 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