MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC

Model Number 67NFPS35

Device Problem Inflation Problem (1310)

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

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for evaluation.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.D5 operator of device is unknown.No information has been provided to date this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that during pre-test, patient mother was trying to inflate the cuff and it did not work despite trying 4-5 times.She then tried again and heard a pop and the cuff then inflated.Mother attempted to fill with water but cuff leaked.She opened two others and the cuff would not inflated on those either.No patient injury reported.

• Brand Name: BIVONA
• Type of Device: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• 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: 15461811
• MDR Text Key: 300326684
• Report Number: 3012307300-2022-19949
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 10351688518798
• UDI-Public: 10351688518798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 67NFPS35
• Device Catalogue Number: 67NFPS35
• Device Lot Number: 4018496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1