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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP 2.6F X 50CM DUAL LUMEN PICC; VASCU-PICC
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MEDCOMP 2.6F X 50CM DUAL LUMEN PICC; VASCU-PICC Back to Search Results
Model Number MR17012601
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/24/2019
Type of Reportable Event Malfunction
Event or Problem Description
While drawing blood/aspirating from one lumen, blood appeared in the other lumen.Possible hole between lumens.
 
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Brand Name
2.6F X 50CM DUAL LUMEN PICC
Common Device Name
VASCU-PICC
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key8591335
Report Number2518902-2019-00029
Device Sequence Number14023660
Product Code LJS
UDI-Device Identifier00884908085693
UDI-Public884908085693
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K102966
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Other
Device Expiration Date09/01/2021
Device Model NumberMR17012601
Device Catalogue NumberMR17012601
Device Lot NumberMNDM260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/08/2019
Supplement Date Received by Manufacturer04/08/2019
Initial Report FDA Received Date05/08/2019
Supplement Report FDA Received Date07/17/2019
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;
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