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

Catalog Number	Z110N-14
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that during suctioning of a patient with a smiths medical portex® suctionpro 72¿ the blue plastic thumb control is noted to be occluding the suction port.It was reported that when the blue piece of the suction unit was pulled forward, it had occluded the suction outlet.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One suction catheter was returned for evaluation.Upon visual inspection, device found to be in good physical condition.The sample underwent functional testing by being submerged under water.No occlusion was noted, and catheter functioned as intended.This testing did not confirm the reported customer complaint.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• 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: 8096758
• Report Number: 3012307300-2018-08303
• Device Sequence Number: 1902939
• Product Code: BSY
• UDI-Device Identifier: 15019315058868
• UDI-Public: 15019315058868
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: Z110N-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1