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/Blood 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.

Manufacturer Narrative

Device evaluation: one used decontaminated sample mp960 epidural flat filter was received.Under visual inspection we noticed that rotating collar is missing on returned sample.Each flat filter contains retention edge which is designed to hold rotating collar connected with filter.Retention edge on returned sample was found to be damaged and therefore it could not hold rotating collar in place.A supplier corrective action request was raised in past against the supplier pall due to similar customer complaints.Based on supplier investigation this defect is user issue caused by rotating collar over tightening.Instructions for use l6300 rev.100, point 3.5 contains following warning: "overtightening the connection between the epidural catheter connector or epidural needle to the male rotating collar may cause rotating collar to dislodge from filter body." the customer reported condition was confirmed.Problem source is user interface.

• 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
• MDR Report Key: 8755048
• MDR Text Key: 149930717
• Report Number: 3012307300-2019-02847
• Device Sequence Number: 1
• Product Code: BSN
• UDI-Device Identifier: 15019315023385
• UDI-Public: 15019315023385
• Combination Product (y/n): N
• PMA/PMN Number: K083451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Expiration Date: 05/03/2023
• 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
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1