MAUDE Adverse Event Report: ST PAUL PORTEX; PAIN MANAGEMENT

Catalog Number NSE4200GCJP

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/28/2021

Event Type  malfunction  

Event Description

Information received a smiths medical pain management|portex kits leaked.During the use of the product, the epifuse connector was found damaged.Also, leakage of fluid medical fluid from it was observed.No patient injury.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection results: as a result of observing the connector, it was confirmed that the hinge was broken.In our kit manufacturing process, 100% inspection is performed on the appearance of epifuse connectors before setting.Therefore, it seems that the hinge part cracked and damaged when using the epifuse connector.The cause of the reported problem could not be determined.Dhr review was completed - review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.

• Brand Name: PORTEX
• Type of Device: PAIN MANAGEMENT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 12380770
• MDR Text Key: 268642641
• Report Number: 3012307300-2021-08933
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2021
• Device Catalogue Number: NSE4200GCJP
• Device Lot Number: 200709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1