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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP VASCU-PICC
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MEDCOMP VASCU-PICC Back to Search Results
Model Number MR17012600
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/14/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a final report will be submitted.
 
Event or Problem Description
"rn called to inform picc line leaking, went to examine, dressing saturated when flushed.Picc line leaking at white hub area.".
 
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Brand Name
VASCU-PICC
Common Device Name
VASCU-PICC
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key7439974
Report Number2518902-2018-00024
Device Sequence Number1095254
Product Code LJS
UDI-Device Identifier00884908093711
UDI-Public884908093711
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/13/2019
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 Other
Device Model NumberMR17012600
Device Catalogue NumberMR17012600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/19/2018
Supplement Date Received by Manufacturer03/19/2018
Initial Report FDA Received Date04/18/2018
Supplement Report FDA Received Date03/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age6 DA
Patient Weight4
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