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

Catalog Number	Z210-14
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a smiths medical portex® suctionpro 72¿ suctioned ineffectively following 6 - 8 hours of use.Subsequently, it was reported that the patient's lung collapsed; leading to a required bronchoscopy being performed.There were no further reported adverse effects.

• Brand Name: PORTEX® SUCTIONPRO 72¿
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7598821
• Report Number: 3012307300-2018-02303
• Device Sequence Number: 1694861
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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?: No
• Operator of Device: No Information
• Device Catalogue Number: Z210-14
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention