MAUDE Adverse Event Report: ST PAUL PORTEX; EPIFUSE

Catalog Number NCE6061JP

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a the pain management|portex kits other epifuse connector.The complaint of hinge broken was verified.No discrepancies found in manufacturing of device.The cause and timing was not identified, however continuous monitoring of the device observed for future trends.

Event Description

Reported a smiths medical pain management|portex kits epifuse connector did not have a problem in connection during the use of it.However, leakage of medical fluid from it was observed.So the customer disconnected the epifuse connector from the mating component and noticed the hinge part was broken.No patient injury.

• Brand Name: PORTEX
• Type of Device: EPIFUSE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11219640
• MDR Text Key: 228395205
• Report Number: 3012307300-2021-00644
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NCE6061JP
• Device Lot Number: 200515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• 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: N
• Patient Sequence Number: 1