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

Model Number HT18FS50NGF113N

Device Problem Leak/Splash (1354)

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

Event Date 08/25/2018

Event Type  malfunction  

Event Description

It was reported that during the cuff integrity check of the device it was found that the cuff was leaking, upon closer investigation the cuff appeared to be torn away.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record (dhr) review.One device received at the investigation site for inspection.Visual inspection was performed with the unaided eye under normal plant lighting and the reported issue of damaged cuff was confirmed.The investigation did not reveal any manufacturing defects with the device.No corrective actions are planned at this time.The root cause was unable to be determined.

• Brand Name: BIVONA TUBES CUSTOM
• 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: 15598159
• MDR Text Key: 306425397
• Report Number: 3012307300-2022-23863
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517156621
• UDI-Public: 15019517156621
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2022

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: Health Professional
• Device Expiration Date: 06/26/2023
• Device Model Number: HT18FS50NGF113N
• Device Catalogue Number: HT18FS50NGF113N
• Device Lot Number: DS017879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1