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

Model Number	Z110-14
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Samples were received in their original unopened package.The samples were visually inspected at a distance of 12 inches under normal lighting conditions for received units.After physical evaluation, failure mode reported can not be confirmed.No broken or damage connector can be observed on the opened sample.Its important to mention that samples sent were new and were unopened, therefore failure mode reported was not confirmed.Samples arrived were new and unopened failure mode for leakage could not be confirmed.After leak test was performed, failure mode for leakage was not confirmed.No other analysis were required.Based on the sample provided, physically evaluation, the failure mode reported was not confirmed; therefore, no root cause can be determined.No corrective actions are required since failure mode was not confirmed.A device history record (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that patient desaturated through the night.Oxygenation improved briefly after closed suctioning.Thick blood clots aspirated when switch to open suctioning.No patient injury reported.

• 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; minneapolis, MN 55442
• MDR Report Key: 15353849
• Report Number: 3012307300-2022-17657
• Device Sequence Number: 12218781
• Product Code: BSY
• UDI-Device Identifier: 15019315034237
• UDI-Public: 15019315034237
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K923559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• 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 Expiration Date: 10/07/2022
• Device Model Number: Z110-14
• Device Catalogue Number: Z110-14
• Device Lot Number: 3878507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic