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

Model Number 67PFSS55

Device Problems Break (1069); Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Manufacturer Narrative

A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.No product sample was received; therefore, no visual and functional testing could be performed.The reported issue could not be confirmed due to the fact that no samples, pictures or videos were received to perform a thorough investigation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device was sent to customer.When it was opened, it was found broken.Eyelet tear.No patient injury was reported.

• Brand Name: BIVONA
• 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: 15427015
• MDR Text Key: 304608685
• Report Number: 3012307300-2022-19243
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518729
• UDI-Public: 10351688518729
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 67PFSS55
• Device Catalogue Number: 67PFSS55
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1