MAUDE Adverse Event Report: NULL BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/22/2022

Event Type  malfunction  

Event Description

It was reported an unknown issue, possible damage to trach tube.After removing the trach from the water it was boiled in, it was discovered there was a tear on the side of it.Lot and part number are unknown.Bivona 4.0 flextend cuffed l41.Discovered prior to use, no patient involvement was reported.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.Visual inspection found no defects with the device.Functional testing successfully passed, and the failure mode reported was not confirmed as the reported problem was not duplicated.No root cause was determined as the sample successfully passed functional testing.No corrective actions were taken as the complaint was not confirmed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# (b)(4).A dhr (device history review) was performed, and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available., corrected data: g2: manufacturing site address is unknown.D4: catalog number is unknown.D4: udi information is unknown.G5: premarket (510k) number is unknown.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 14778015
• MDR Text Key: 294533874
• Report Number: 3012307300-2022-12387
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1