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

Model Number 67PFSS35

Device Problems Inflation Problem (1310); Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Event Description

It was reported two trachs with issues.One trach cuff has a hole and another cuff was inflating asymmetrically.No patient injury was reported.

Manufacturer Narrative

Other, six (6) samples were received with their original lid and labelling and without their original packaging, in used conditions and with their certificate of decontamination.Samples were filled with 5cc of air in order to see if there was any functional problem; after the whole cuff inflated, the cuff was deflated and inflated 4 times, all the times the cuff inflated completely and without problems.Leak test: when sample 1 was submerged under water, a leak was detected on the inflation line, a big cut was found during the test.No leaks were found in sample 2,3,4,5 and 6.The complaint is confirmed.Then air cuff symmetry test was performed.When measured the cuffs, the percentage for the symmetry were over 33.3% that is the minimum acceptable.Based on the test, the units are within specification.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: 15418069
• MDR Text Key: 300247075
• Report Number: 3012307300-2022-19122
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518682
• UDI-Public: 10351688518682
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 67PFSS35
• Device Catalogue Number: 67PFSS35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• 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