MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. UNSPECIFIED UNIPERC TRACHEOSTOMY TUBE SIZE 7; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 10/01/2023

Event Type  Injury  

Event Description

It was reported that after surgery, the patient's cannula had slipped out of the stoma and the lock was open.The patient was able to breathe as a preventative measure was setup before the surgery.A few days later on the 25th the patient had breathing problems.The doctor examined the patient and saw that the locks had slipped up again and the cannula was slipping out of trachea.The patient was not injured.

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: month and year of event have been provided, but day is unknown.D4.Catalog, lot number, udi, expiration date 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 including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: UNSPECIFIED UNIPERC TRACHEOSTOMY TUBE SIZE 7
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18734689
• MDR Text Key: 335715180
• Report Number: 2183161-2024-00147
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• 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
• Patient Outcome(s): Required Intervention