MAUDE Adverse Event Report: NULL; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 200408

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

One epifuse connector was returned with a flat filter.Analysts found that the issue was confirmed.The hinge was found to be broken.In our kit manufacturing process, 100% inspection is performed on the appearance of epifuse connectors before installation.Therefore, it seems that the hinge part cracked and damaged when using the epifuse connector.However, the cause and timing of occurrence were not identified.Customer facility phone number: (b)(6).

Event Description

Information was received indicating that a smiths medical tubing was leaking medical fluid from the epifuse connector.There were no reported adverse events.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 11038197
• MDR Text Key: 222367571
• Report Number: 3012307300-2020-12547
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 200408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2020
• 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: Unknown
• Patient Sequence Number: 1