MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACK; ANESTHESIA CONDUCTION KIT

Catalog Number 100/491/718

Device Problems Fluid/Blood Leak (1250); Defective Component (2292); Fail-Safe Problem (2936)

Patient Problem Dyspnea (1816)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Foreign - report source: (b)(6).User facility: (b)(6) hospital op recovery room.

Event Description

Information was received that a smiths medical portex csecure spinal and epidural needle assemblies - minipack leaked medicine and did not lock during pre-testing in a hospital op recovery room.The reporter also stated that the patient "had a hard time in breathing".Additionally, it was noted that no medical intervention was required.No additional adverse patient effects were reported.

Manufacturer Narrative

Device evaluation: two spinal needles, catheter connectors, epifuse epidural luers, luer slips, and a flat filter were returned from the customer for investigation.The returned components were accompanied by a certificate of safe handling.From the complaint description it was determined that the component which leaked and did not locked was the catheter connector component.The affected components were tested against the requirements and no issues were found.The returned items passed inspection.No leakage was observed.Based on the investigation, the complaint allegation was not confirmed.No fault was found with the device or its components.

• Brand Name: PORTEX CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACK
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8678951
• MDR Text Key: 147336763
• Report Number: 3012307300-2019-03241
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2023
• Device Catalogue Number: 100/491/718
• Device Lot Number: 3620750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1