MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL FILTER, FLAT WITH LUER LOCK FILTER, CONDUCTION, ANESTHETIC

Model Number 100/386/010

Device Problems Fluid Leak (1250); Defective Component (2292); Detachment of Device or Device Component (2907); Incomplete or Inadequate Connection (4037)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Type  malfunction  

Manufacturer Narrative

Foreign - report source: (b)(6).

Event Description

Information was received that the soldered coupling of a smiths medical portex epidural filter, flat with luer lock was released, causing the connection on the eda filter to break during patient infusion. It was also noted there was a small leakage next to the hose. Subsequently, the patient experienced breakthrough pain, but no additional adverse patient effects were reported.

• Brand Name: PORTEX EPIDURAL FILTER, FLAT WITH LUER LOCK
• Type of Device: FILTER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8755048
• MDR Text Key: 149930717
• Report Number: 3012307300-2019-02847
• Device Sequence Number: 1
• Product Code: BSN
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K083451
• 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: 09/19/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 100/386/010
• Device Catalogue Number: 100/386/010
• Device Lot Number: 3633743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial