MAUDE Adverse Event Report: Q CORE MEDICAL LTD. AP 433-01; ADMINISTRATION SET

Model Number	12000-000-0029
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Exemption number, e2014005.(b)(4).
Event or Problem Description
Hold mallika banerjee 6/22/20 the complaint was reported by a customer from (b)(6): leakage of administration set.The awareness date of this report is jun.26th, 2017.

• Brand Name: AP 433-01
• 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 Key: 6736023
• Report Number: 3010293992-2017-00114
• Device Sequence Number: 3303771
• Product Code: FPA
• UDI-Device Identifier: 17290109150533
• UDI-Public: 17290109150533
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12000-000-0029
• Device Catalogue Number: 12000-000-0029-00
• Device Lot Number: 57-200-5G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 07/24/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown