5F DUAL VASCU-PICC MR17015206

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-02 for 5F DUAL VASCU-PICC MR17015206 manufactured by Medcomp.

Event Text Entries

[4911771] Staff nurse noted swelling to the extremity where the picc line was inserted. The picc line was removed and an ultrasound was ordered by the md. Ultrasound reveals that there is no evidence of thrombosis in the left upper extremity.
Patient Sequence No: 1, Text Type: D, B5


[12423005] An investigation has been initiated. When the investigation is complete a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2518902-2014-00064
MDR Report Key4142704
Report Source05,06
Date Received2014-10-02
Date of Report2014-10-01
Date of Event2014-08-30
Date Mfgr Received2014-09-08
Device Manufacturer Date2014-03-28
Date Added to Maude2014-10-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSUSAN SMITH, RN
Manufacturer Street1499 DELP DR.
Manufacturer CityHARLEYSVILLE PA 19438
Manufacturer CountryUS
Manufacturer Postal19438
Manufacturer Phone2152564201
Manufacturer G1MEDCOMP
Manufacturer Street1499 DELP DR.
Manufacturer CityHARLEYSVILLE PA 19438
Manufacturer CountryUS
Manufacturer Postal Code19438
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5F DUAL VASCU-PICC
Generic NameINFUSION CATHETER
Product CodeJCY
Date Received2014-10-02
Returned To Mfg2014-09-08
Model NumberMR17015206
Catalog NumberMR17015206
Lot NumberMBSX660
ID NumberNA
Device Expiration Date2016-04-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDCOMP
Manufacturer AddressHARLEYSVILLE PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-10-02

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