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

Model Number	Z110-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.As part of the investigation no photos were included.The reported failure mode was not confirmed because no photos were included nor attached, the only information received to be confirmed was the lot number, and the product description that matches with the description reported for the product.Ten samples units were received, one of them with its opened original package due it was intended for use by customer, the rest of the 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, the failure mode of broken connector was not confirmed.No broken or damage connector can be observed on the opened sample.Also the remaining samples that were unopened were visually inspected and failure mode reported was not confirmed.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, all mitigations on placed were verified and it was confirmed execution accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that suction catheter was broken in the "t" area.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: 15353886
• Report Number: 3012307300-2022-17689
• Device Sequence Number: 12228328
• Product Code: BSY
• UDI-Device Identifier: 15019315034237
• UDI-Public: 15019315034237
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2022

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: 07/20/2023
• Device Model Number: Z110-14
• Device Catalogue Number: Z110-14
• Device Lot Number: 3985151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2020
• 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 Sex: Unknown