CENTURION ECVC3545

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-07-28 for CENTURION ECVC3545 manufactured by Centurion Medical Products.

Event Text Entries

[50713354] Multiple attempts to gather additional information from the initial reporter were unsuccessful. Nevertheless, it's unlikely the reported patient experience is attributable to the device itself.
Patient Sequence No: 1, Text Type: N, H10


[50713355] Patient experienced cardiac arrhythmia (afib) after the removal of a cracked catheter.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1038445-2016-00001
MDR Report Key5831101
Report SourceUSER FACILITY
Date Received2016-07-28
Date of Report2016-07-28
Date of Event2016-06-21
Date Mfgr Received2016-06-29
Device Manufacturer Date2015-11-20
Date Added to Maude2016-07-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MATTHEW PRICE
Manufacturer Street100 CENTURION WAY
Manufacturer CityWILLIAMSTON MI 48895
Manufacturer CountryUS
Manufacturer Postal48895
Manufacturer Phone5175451135
Manufacturer G1CENTURION MEDICAL PRODUCTS
Manufacturer Street3310 S MAIN ST.
Manufacturer CitySALISBURY NC 28147
Manufacturer CountryUS
Manufacturer Postal Code28147
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCENTURION
Generic NameINTRAVASCULAR CATHETER
Product CodeOES
Date Received2016-07-28
Model NumberECVC3545
Lot Number2015111150
Device Expiration Date2017-06-30
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCENTURION MEDICAL PRODUCTS
Manufacturer Address3310 S MAIN ST. SALISBURY NC 28147 US 28147


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-07-28

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