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

Model Number FT21IN60NGF057N

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported that a total of 2 individual tracheal cannula experience a nightly loss of aqua volume (3ml in, 1.5ml out).Suspicion of leakage at the pilot.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation: visual inspection of the two returned devices did not identify any defects.The devices were leak tested per work instruction, (b)(4).No leaks were detected.The cuffs were inflated with 10 cc of water and the various portions of the inflation system were manipulated.No leaks were detected.The devices with 10 cc of water in the cuffs were allowed to rest several days.No leaks were evident while the device was resting.Using a syringe, the water was evacuated.Approximately 10 cc of water was removed, the minor difference is accounted for the small amount of water that remains in the inflation system.Based on the limited information in the complaint description, it is unknown what the caregiver used to inflate the cuffs, but using air would account for the nightly loss in volume.The reported problem could not be confirmed.No corrective actions are planned at this time.There were no non-conforming reports (ncrs) initiated for the lots or anomalies identified in the dhrs.

• Brand Name: BIVONA TUBES CUSTOM
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13636085
• MDR Text Key: 286356090
• Report Number: 3012307300-2022-04229
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517280845
• UDI-Public: 15019517280845
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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 Model Number: FT21IN60NGF057N
• Device Catalogue Number: FT21IN60NGF057N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1