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

Model Number	Z210-14
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.The sample had the catheter wiper seal out of place.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample was tested and successfully passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
Event or Problem Description
It was reported that upon the use of the product, the customer noticed the sleeve was expanding before performing suction.No patient injury.

• Brand Name: PORTEX SUCTIONPRO 72
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12 kitanagase-omote-machi; minneapolis, MN 55442
• MDR Report Key: 15353831
• Report Number: 3012307300-2022-17645
• Device Sequence Number: 5998367
• Product Code: BSY
• UDI-Device Identifier: 15019315046902
• UDI-Public: 15019315046902
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2022

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: Other
• Device Model Number: Z210-14
• Device Catalogue Number: Z210-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown