MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, ADULT; TUBE TRACHEOSTOMY AND TUBE CUFF

Lot Number UNKNOWN

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Event Description

It was reported that the introducers/obturators did not line up or match total length of the tracheostomy tubes needed for placement; even if switched, one was still too long and the other too short.No patient injury was reported.

Manufacturer Narrative

No additional information was provided.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).No lot number was provided; therefore, a device history record (dhr) review could not be completed on the actual suspect device.Since no lot number was provided, a dhr review was performed on the two most recent orders for the part number: from 2 lots for a quantity of (b)(4) units, manufactured on 16-jul-2018 and on 29-aug-2018.The returned complaint samples were visually inspected by the naked eye under normal plant lighting.Both devices appeared to have been used.The print on the returned samples was very light and in some areas it was worn away.The devices were inspected per the template for the part number.One matched the template and the other did not.The 1b measurement (i.E., the part of the device that is inserted into the stoma) for the shafts was different.The 1a measurement (i.E., the part of the device that extends outside the body) was the same for both devices.As part of final inspection, the devices are inspected and measurements recorded for the obturator protrusion, shaft length (1a and 1b), and print clarity and accuracy.All required inspections passed by meeting the specifications identified on the prescription template and by meeting additional manufacturing requirements.The returned devices were determined not to be the same part number.The device with the shorter 1b measurement is not of the same part number.That device also is the one with the length measurement worn and not readable.Since there is no evidence in the reviewed dhr documents to support that a device was built with the incorrect length, it is hypothesized that the one device was switched in a clinical setting where multiple products are being reprocessed.The root cause of the issue could not be determined.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 15605530
• MDR Text Key: 306702307
• Report Number: 3012307300-2022-24022
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1