MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX SUCTIONAID TRACHEOSTOMY TUBE W/ SOFT SEAL CUFF; BTO - TRACHEOSTOMY TUBES

Catalog Number 100/515/080

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problems Low Oxygen Saturation (2477); Therapy/non-surgical treatment, additional (2519)

Event Date 03/13/2014

Event Type  Injury  

Event Description

A report was received stating that during use of the listed device the patient's ventilator alarmed to warn that the patient's spo2 was low.The clinician inserted a suction catheter to suction the tube.According to the report, the suction catheter became lodged within the tube.An emergent exchange of the tracheostomy tube was then performed.The report states that the clinician inspected the tube once removed and found no occlusion.No incident related medical sequela was reported.

Manufacturer Narrative

Manufacturer completed the entire form.The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.A sample device was returned and is currently under investigation.

• Brand Name: PORTEX SUCTIONAID TRACHEOSTOMY TUBE W/ SOFT SEAL CUFF
• Type of Device: BTO - TRACHEOSTOMY TUBES
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundry road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3760962
• MDR Text Key: 16012599
• Report Number: 2183502-2014-00210
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/515/080
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2014
• Distributor Facility Aware Date: 03/13/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other