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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 Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/08/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.
 
Event or Problem Description
Lumen broke-lu arm.
 
Additional Manufacturer Narrative
Based on sample review, ifu review, and test results, it was concluded that the device reported is manufactured according to specification.Dhr could not be reviewed because the lot number was not reported.Damage to lumen does not appear to be related to the manufacturing process.The device was implanted in the arm of a 15-month-old.The catheter may have been stressed beyond the design capabilities.
 
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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 Key7479112
Report Number2518902-2018-00027
Device Sequence Number16345285
Product Code LJS
UDI-Device Identifier00884908085693
UDI-Public884908085693
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K102966
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 01/24/2019
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? No
Operator of Device Other
Device Model NumberMR17012601
Device Catalogue NumberMR17012601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/02/2018
Supplement Date Received by Manufacturer04/02/2018
Initial Report FDA Received Date05/02/2018
Supplement Report FDA Received Date01/24/2019
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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