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

Model Number 24-1000-64

Device Problem Fluid Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2020

Event Type  malfunction  

Event 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.

• Brand Name: PORTEX EPIDURAL FILTERS
• Type of Device: FILTER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 3350 granada avenue north; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10048951
• MDR Text Key: 190683029
• Report Number: 3012307300-2020-04010
• Device Sequence Number: 1
• Product Code: BSN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage