MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG PORTEX® ENDOBRONCHIAL DOUBLE LUMEN; TUBE, TRACHEAL/BRONCHIAL

Catalog Number 198-32L

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

The user facility reported that during use, the fiberscope would not smoothly enter the endobronchial tube.It was reported that upon removal of the endobronchial tube, kinking was observed.According to the user facility, the fiberscope was damaged after patient use.No patient injury reported.

Manufacturer Narrative

The reported endobronchial tube 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 and no kinks/dents were observed in the returned device by the customer.(b)(4).

• Brand Name: PORTEX® ENDOBRONCHIAL DOUBLE LUMEN
• Type of Device: TUBE, TRACHEAL/BRONCHIAL
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a. de c.v. ave, calidad no.; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave, calidad no.; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5806090
• MDR Text Key: 49906297
• Report Number: 2183502-2016-01526
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 198-32L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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