MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 67PFSS40

Device Problem Defective Component (2292)

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

Event Date 10/24/2018

Event Type  malfunction  

Event Description

It was reported that 5 trachs were defective.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Unique identifier and 510k.Are unknown.No information has been provided to date.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Two (2) samples were received.Samples were received in used conditions without their original packaging.Visual inspection was performed at 12 under normal conditions of illumination in order to detect any damage on the part.During the visual inspection, a white substance was observed inside the air line from sample.Sample 1 was filled with 5 cubic centimeter (cc) of air in order to see if there was any problem with the unit.When inflating the sample 1 with air, it was required extreme force to inflate the cuff.When the cuff was inflated.It was not possible to deflate.Sample was cut with a razor in order to see if the unit was blocked.After cut, it was found a white substance inside the air line.When inflating the sample 2 with air, it was observed that part wasnt inflated uniformly.According to the information for use (ifu) the cuff was manipulated and the whole cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff was inflated completely.After a review of the different verifications that are performed during the manufacturing process to detect inflation problems, the root cause of the reported issue could not be confirmed during evaluation; however, the most probable root cause is that damage occurred after the device left the manufacturing site.As a preventive action production personnel was notified by area trainer as awareness of the defect reported by the customer.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 15657412
• MDR Text Key: 306992136
• Report Number: 3012307300-2022-26017
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Catalogue Number: 67PFSS40
• Device Lot Number: 3363021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1