MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/515/080

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A preliminary evaluation has been performed which confirms a leaking area on the cuff.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.An actual date of event was not noted in the complaint.Only that the event happened (b)(6), 2016.Evaluation in progress.

Event Description

This event occured in (b)(6).The user facility reported that the patient had a cuff leakage one hour after use.Unknown patient injury.

Manufacturer Narrative

The reported suctionaid tracheostomy 8.0mm soft seal cuff was returned for investigation.The returned device was received inside a plastic bag and without its original packaging.Visual inspection was at a distance of 12" to 24" and normal conditions of illumination.The cuff of the returned sample was inflated using a syringe and the product and was submerged under water in order to detect any leakage.Leakage was observed coming out from the small tear.Root cause was not determined.(b)(4).

• Brand Name: PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana 55425 ; MX 55425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana 55425 ; MX 55425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5767993
• MDR Text Key: 48712624
• Report Number: 2183502-2016-01328
• 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: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/515/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1