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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Q CORE MEDICAL LTD. AP331-01; ADMINISTRATION SET
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Q CORE MEDICAL LTD. AP331-01; ADMINISTRATION SET Back to Search Results
Model Number 12007-000-0005
Date of Event 05/16/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.(b)(4).
 
Event or Problem Description
The event was reported by a customer from usa: administration set leakage of chemotherapy.
 
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Brand Name
AP331-01
Common Device Name
ADMINISTRATION SET
Manufacturer (Section D)
Q CORE MEDICAL LTD.
yad haruzim st. 29
netanya, 42505 29
IS  4250529
Manufacturer (Section G)
Q CORE MEDICAL LTD.
yad haruzim st. 29
netanya, 42505 29
IS   4250529
Manufacturer Contact
judith antler
yad haruzim st. 29
netanya, 42505-29
IS   4250529
MDR Report Key6649492
Report Number3010293992-2017-00093
Device Sequence Number2089558
Product Code FPA
UDI-Device Identifier17290109150427
UDI-Public17290109150427
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K141834
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/18/2016
1 Device was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model Number12007-000-0005
Device Catalogue Number12007-000-0005
Device Lot Number61-198-5G
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/29/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date06/19/2017
Supplement Report FDA Received Date06/19/2017
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
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