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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARLINK INTRAVENOUS EXTENSION TUBING KITS SET, ADMINISTRATION, INTRAVASCULAR

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CLEARLINK INTRAVENOUS EXTENSION TUBING KITS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number EMC9190
Device Problems Fitting Problem (2183); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that two (2) clearlink iv catheter ext. Sets had mold, preventing them from connecting. This issue was identified during setup and preparation prior to patient use. There was no patient involvement. No additional information is available.
 
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Brand NameCLEARLINK INTRAVENOUS EXTENSION TUBING KITS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12367345
MDR Text Key268136264
Report Number1416980-2021-05226
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberEMC9190
Device Lot Number20G18T106
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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