MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. MEDEX; STOPCOCK, I.V. SET

Catalog Number MX1483CZ

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

Customer contact phone number: (b)(6).Customer contact email: (b)(6).The physical device was not returned for device evaluation.A photograph of the affected product was examined.After comparing the provided photograph of the medex filter, to that of a drawing for the item number of the affected product (mx1483cz), the investigator was unable to confirm if the separation was caused by insufficient glue application within the assembly, or by manual handling.The reported product problem could not be verified from just the photographic examination alone.A root cause was not established.

Event Description

It was reported that the medex filter detached from the infusion system.The particulate filter became loose at the weld seam.The parenteral nutrition leaked out as a result.The pump did not produce an alarm because there was no pressure.No patient injury or complications were reported in relation to this event.Additional information was requested but has not yet been received.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

A photo was received and analyzed.No product was returned for analysis.The returned photo did not have the affected products in it and could not be used for analysis.Issue could not be confirmed.

• Brand Name: MEDEX
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 11995104
• MDR Text Key: 256059645
• Report Number: 3012307300-2021-05990
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MX1483CZ
• Device Lot Number: 4052509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1