MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; EPIDUARAL

Catalog Number A3565-17

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2021

Event Type  malfunction  

Event Description

Information received a smiths medical pain management|portex epidural custom single shot trays malfunctioned.The customer reported filters come loose during care with the patient not receiving adequate pain control.With tubing not attached.Several related complaints were reported.

• Brand Name: PORTEX
• Type of Device: EPIDUARAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 12108067
• MDR Text Key: 259652198
• Report Number: 3012307300-2021-06777
• 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: foreign,user facility
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: A3565-17
• Device Lot Number: 4102093
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1