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

Model Number FT22AN40NGE999N

Device Problem Leak/Splash (1354)

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

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported that the cuff was busted and leaking.No additional information.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: the device was returned for investigation.The returned product was reviewed and found to have a large hole in the cuff which was immediately confirmed to prohibit the cuff from being inflated.Custom devices are 200% leaked tested prior to packaging, which requires the cuffs to be inflated and deflated.Per the complaint description, it was implied that the devices operated appropriately prior to the cuff becoming damaged (i.E.The customer says that this was noted during testing before a routine trach change).It is unknown what caused the cuff to become damaged, however it is highly unlikely to have become damaged prior to leaving the manufacturing facility due to the reasons explained above.Based on this finding, no corrections or corrective actions are planned at this time.Icu medical routinely monitors post-market data for additional information and trends, which could lead to further action being deemed appropriate in the future.The dhr specified by the customer (st009830) was reviewed.No discrepancies or non-conformances were noted for this lot number.

• 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: 14135554
• MDR Text Key: 289443920
• Report Number: 3012307300-2022-06506
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517291162
• UDI-Public: 15019517291162
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

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: FT22AN40NGE999N
• Device Catalogue Number: FT22AN40NGE999N
• Device Lot Number: ST009830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1