MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SUCTIONPRO 72¿; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Catalog Number	Z210-14
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that this closed ventilation suction system did not suction efficiently.This was discovered about 6-8 minutes after use.The patient suffered a lung collapse and required bronchoscopy.No additional adverse patient effects were reported.

• Brand Name: PORTEX® SUCTIONPRO 72¿
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7567173
• Report Number: 3012307300-2018-02198
• Device Sequence Number: 1524339
• Product Code: BSY
• UDI-Device Identifier: 15019315046902
• UDI-Public: 15019315046902
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K923559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: Z210-14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/04/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention