MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA NEONATAL TIGHT TO SHAFT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 67N035

Device Problems Disconnection (1171); Inflation Problem (1310)

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

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that the patient had a decannulated trach.The trach was replaced with "emergency equipment".A decision was made to upsize the trach.A second product failure occurred for the same patient during the equipment check of the upsized product.That malfunction will be reported under emdr-18428.A third new trach had to be used.There was no negative outcome.Only a delay in the new trach insertion."patient had patent trach in.The cuff did not inflate fully circumferential.Concern was that the attempt to inflate the cuff may have blown the cuff in the process.".

Manufacturer Narrative

Investigation summary: the sample returned consisted of one (1) for p/n: 67n035 and lot: 4016046, and was received in used condition, in a plastic bag.During the visual inspection it was identified that the cuff was completely broken.The failure mode of ¿will not inflate¿ was not confirmed, and "broken cuff" was confirmed.The root cause was not determined.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA NEONATAL TIGHT TO SHAFT
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19038077
• MDR Text Key: 339321046
• Report Number: 9617604-2024-00285
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006223
• UDI-Public: (01)15021312006223(17)250616(10)4016046
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 67N035
• Device Lot Number: 4016046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention