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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP 2.6FX50CM DL LMN VASCU-PICC
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MEDCOMP 2.6FX50CM DL LMN VASCU-PICC Back to Search Results
Model Number MR17022601
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/16/2017
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
Line clotted-tpa used and line broke.The line was removed and replaced with a new one.
 
Additional Manufacturer Narrative
Inspection records, device history records and inspection of the returned sample were performed.The root cause of the failure could not be determined.
 
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Brand Name
2.6FX50CM DL LMN VASCU-PICC
Common Device Name
VASCU-PICC
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key6814731
Report Number2518902-2017-00043
Device Sequence Number16413475
Product Code LJS
UDI-Device Identifier00884908105186
UDI-Public884908105186
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K102966
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/20/2017
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 Date10/03/2019
Device Model NumberMR17022601
Device Catalogue NumberMR17022601
Device Lot NumberMHVW130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2017
Initial Date Received by Manufacturer 07/26/2017
Supplement Date Received by Manufacturer07/26/2017
Initial Report FDA Received Date08/23/2017
Supplement Report FDA Received Date10/20/2017
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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