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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDEX; SET, ADMINISTRATION, INTRAVASCULAR
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MEDEX; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MX448F78MG
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/05/2021
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that a smiths medical extension set was leaking during use with iv fluid with nicu patients.There were no reported adverse events.
 
Additional Manufacturer Narrative
Other, other text: 29 devices were returned for investigation.A leak test was done on all devices with 6 devices leaking at the male end of the stopcock and male luer lock.This was found to be due to not enough solvent in the area.Root cause analysis traced this issue to manufacturing.
 
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Brand Name
MEDEX
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12020803
Report Number3012307300-2021-06203
Device Sequence Number16487993
Product Code FPA
UDI-Device Identifier10351688518842
UDI-Public10351688518842
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/09/2021
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
Operator of Device Health Professional
Device Model NumberMX448F78MG
Device Lot Number4079669
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/20/2021
Supplement Date Received by Manufacturer08/06/2021
Initial Report FDA Received Date06/17/2021
Supplement Report FDA Received Date09/09/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
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