MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® ENDOBRONCHIAL DOUBLE LUMEN TUBE; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Catalog Number 198-35L

Device Problems Device Alarm System (1012); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).

Event Description

It was reported that a portex® endobronchial double lumen tube cap had come off, which had triggered an alarm from an anesthetic device, during use with a patient.No patient injury was reported.See mfr: 3012307300-2016-00675 and 3012307300-2016-00692.

Manufacturer Narrative

Please note, additional information was received regarding related mfr file number 3012307300-2016-00692.According to the reporter, it is unknown if the two events involve the same patient.

Event Description

It was further reported that the device was in use for one hour before the reported event was observed.According to the reporter, the incident did not result in the need for medical intervention and the patient did not experience injury.It was reported that the incident was resolved.According to the reporter, the device was tested prior to patient use.It was reported that no patient information is available.

• Brand Name: PORTEX® ENDOBRONCHIAL DOUBLE LUMEN TUBE
• Type of Device: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6216358
• MDR Text Key: 63690085
• Report Number: 3012307300-2016-00693
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 198-35L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2016
• 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