MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CATHETERS SUCTIONPRO 72; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

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
This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.A product sample was received for evaluation.Visual and functional testing were performed.One sample was received in used conditions, without its original packaging.The sample was visually inspected with a 12 inches distance under normal conditions of illumination.During the visual inspection, the sample showed the trach cross was broken.The root cause was unable to be determined.No corrective actions are required since it?s unlikely that trach cross broke during the manufacturing process.A notification of the reported failure mode to the production personnel.
Event or Problem Description
It was reported that the connector piece that goes into the ventilator circuit broke while in use on a patient.No patient injury was reported.

• Brand Name: PORTEX CATHETERS SUCTIONPRO 72
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 15674663
• Report Number: 3012307300-2022-26271
• Device Sequence Number: 20448802
• Product Code: BSY
• UDI-Device Identifier: 15019315034237
• UDI-Public: 15019315034237
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/26/2022

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: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: Z110-14
• Device Catalogue Number: Z110-14
• Device Lot Number: 3653783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2018
• 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