MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; EPIDURAL FILTER

Model Number	100/386/010
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product, medical fluid leaked from the flat filter.No patient injury was reported.
Additional Manufacturer Narrative
Summary of investigation: actual device was available for investigation.One used mp960 epidural flat filter and a syringe (not part of reported epidural minipack) were received in plastic bag without its original packaging (see photo of samples).Under visual inspection we noticed that epidural flat filter has app.4mm long crack on its cover (see photo of defect).Then filter was flushed by syringe filled with water and leak was immediately observed from cracked area (see photo of testing).Without any lot number provided by customer we are unable to confirm if reported flat filter was manufactured prior or after implementation of corrective actions.As no lot number was provided, no dhr was possible.

• Brand Name: PORTEX
• Common Device Name: EPIDURAL FILTER
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13115033
• Report Number: 3012307300-2021-13492
• Device Sequence Number: 20063636
• Product Code: BSN
• UDI-Device Identifier: 15019315023385
• UDI-Public: 15019315023385
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2021

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 Model Number: 100/386/010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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