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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDEX INFUSION EXTENSION SETS AND DISPOSABLES MEDEX

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MEDEX INFUSION EXTENSION SETS AND DISPOSABLES MEDEX Back to Search Results
Model Number SX720448CZ
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Manufacturer Narrative
Corrected data: phone number (b)(6).
 
Event Description
It was reported that the tpn fluid was staining the patient bed. Tpn was leaking from one of the filters.
 
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Brand NameMEDEX
Type of DeviceINFUSION EXTENSION SETS AND DISPOSABLES MEDEX
MDR Report Key12682821
MDR Text Key277934870
Report Number3012307300-2021-10178
Device Sequence Number1
Product Code OJA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSX720448CZ
Device Lot Number4129484
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/21/2021
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
Type of Device Usage

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