MAUDE Adverse Event Report: ST PAUL PAIN MANAGEMENT; EPIDURAL

Catalog Number NCE6270JP

Device Problems Leak/Splash (1354); Separation Failure (2547)

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

Event Date 03/01/2021

Event Type  malfunction  

Event Description

Information received a smiths medical pain management|portex kits other malfunctioned.Reported after the indwelling the catheter was in the patient, the customer was performing a dose test, he then found leakage of medical fluid from the connector.This event occurred in the two products.Also, he noticed one of the catheters was broken into two.No patient injury.

• Brand Name: PAIN MANAGEMENT
• Type of Device: EPIDURAL
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11709101
• MDR Text Key: 246955633
• Report Number: 3012307300-2021-03386
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NCE6270JP
• Device Lot Number: 201022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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