MAUDE Adverse Event Report: NULL MEDEX BIFURCATED FLUID ADMINISTRATION SET; SET, I.V. FLUID TRANSFER

Catalog Number MX6773

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

It was reported that the device is cracked and leaking during transfusion.No additional information.

Manufacturer Narrative

No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was performed, and no issues were noted during manufacture.No root cause could be determined as the complaint could not be confirmed.An awareness meeting with operators and quality inspectors about the failure mode reported was held.

• Brand Name: MEDEX BIFURCATED FLUID ADMINISTRATION SET
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section G): NULL
• MDR Report Key: 14365689
• MDR Text Key: 291498316
• Report Number: 3012307300-2022-08586
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX6773
• Device Lot Number: 4218409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1