MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. UNSPECIFIED BIVONA SILICONE TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number UNKNOWN

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: a catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, smiths medical corporate headquarters in oakdale, mn has been listed in sections d3.And g1.And the oakdale fda registration number has been used for the manufacture report number.B3.Date of event: unknown.No information has been provided to date.D4.Lot number, expiration date, udi, and h4.Manufacture date are unknown; no information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.A device history record could not be completed as no lot number was received.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that the cuff couldn't be inflated.When adding air to the water cuff for testing, only one side filled up, or nothing filled up at all.There was unknown patient involvement and unknown patient harm/adverse event reported.

• Brand Name: UNSPECIFIED BIVONA SILICONE TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18897705
• MDR Text Key: 337732502
• Report Number: 9617604-2024-00229
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1