MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX EPIDURAL FILTERS; FILTER, CONDUCTION, ANESTHETIC

Model Number	24-1000-64
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer connected the product (a flat filter) to a third party's product and started administration of medical fluid.About 7 hours later, medical fluid leaked from the filter.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
One portex epidural filter was returned with a third-party connector attached for analysis.Water was injected from a syringe through the connected; no leakage observed.Water was then injected into the flat filter alone; no leakage confirmed.Based on the evidence, there was no fault found as the complaint was not confirmed.

• Brand Name: PORTEX EPIDURAL FILTERS
• Common Device Name: FILTER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10048951
• Report Number: 3012307300-2020-04010
• Device Sequence Number: 18999373
• Product Code: BSN
• UDI-Device Identifier: 15019517054651
• UDI-Public: 15019517054651
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 24-1000-64
• Device Catalogue Number: 24-1000-64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1