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

Model Number	Z210-12
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A review of the device history records showed there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.No product sample was received; therefore, visual and functional testing could not be performed.The investigation of this complaint was done based on photo.From pictures received it is observed that the sample sleeve was broken.The most probable cause is that the damage was caused after the product left the facility.The root cause was unable to be determined.No corrective actions are required since its unlikely that sleeve broke during the manufacturing process.
Event or Problem Description
It was reported that the product was defective.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: 15673528
• Report Number: 3012307300-2022-26251
• Device Sequence Number: 15046047
• Product Code: BSY
• UDI-Device Identifier: 15019315046896
• UDI-Public: 15019315046896
• Combination Product (Y/N): N
• 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: Other
• 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: 04/12/2020
• Device Model Number: Z210-12
• Device Catalogue Number: Z210-12
• Device Lot Number: 3384353
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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