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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL ARTERIAL CANNULA CANNULA, CATHETER

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SORIN GROUP ITALIA SRL ARTERIAL CANNULA CANNULA, CATHETER Back to Search Results
Model Number A212-65C
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2019
Event Type  malfunction  
Manufacturer Narrative
Patient information were not provided. The age of the device was calculated as the time elapsed between device sterilization and the date of the event. (b)(4). Sorin group (b)(4) manufactures the arterial cannula. The incident occurred in (b)(6). Per exemption number e2016005, sorin group (b)(4) is submitting the report for both sorin group (b)(4) (manufacturer) and livanova usa. , inc. (b)(4). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The involved device has been requested for return to sorin group (b)(4) for investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not yet returned.
 
Event Description
Sorin group (b)(4) has been informed that upon insertion of the arterial cannula, the cap at the end of the cannula fell off and blood flowed onto the surgeon. There is no report of any patient/user injury.
 
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Brand NameARTERIAL CANNULA
Type of DeviceCANNULA, CATHETER
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola, modena
Manufacturer (Section G)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola, modena 41037
IT 41037
Manufacturer Contact
enrico greco
14401 w 65th way
arvada, CO 80004
MDR Report Key8716670
MDR Text Key179419922
Report Number9680841-2019-00025
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K870826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/19/2021
Device Model NumberA212-65C
Device Catalogue NumberA212-65C
Device Lot Number1806200027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Device Age13 MO
Event Location No Information
Date Manufacturer Received09/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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