MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX UNIPERC ADJUSTABLE FLANGE EXTENDED- LENGTH TRACHEOSTOMY TUBES

Model Number 100/897/070

Device Problem Connection Problem (2900)

Patient Problem Extubate (2402)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

Report received stating that while tube was in use with patient, the "tube came apart" at the 15 mm connector.The event was observed by anaesthetic ct2 during patient repositioning.Staff held the tube together and informed anaesthetist who re-intubated the patient immediately.No further adverse effects to patient reported.

Manufacturer Narrative

A 7.0mm uniperc cuffed tube and 7.0mm inner cannula were returned for evaluation.The devices were received inside a plastic bag without their original packaging.During visual inspection, the 15mm white connector was found disconnected from the tracheostomy tube.It is likely that the reported failure was a result of an inadequate bonding process.Evaluation determined that the root cause of the disconnection was related to a manufacturing issue and was an exception to the initial manufacturing of the device.Additional information included in follow-up report: date device was received (04/06/2016).Evaluation completion date (08/01/2016).

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE EXTENDED- LENGTH TRACHEOSTOMY TUBES
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer (Section G): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5293191
• MDR Text Key: 33392811
• Report Number: 2183502-2015-00965
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100/897/070
• Device Catalogue Number: 100/897/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/25/2016; 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other