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

Model Number Z110-14

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 305603512
• Report Number: 3012307300-2022-17657
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 15019315034237
• UDI-Public: 15019315034237
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K923559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic