MAUDE Adverse Event Report: Q CORE MEDICAL LTD. AP202 -INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND 0.2 FILTER, NEEDLE Y; ADMINISTRATION SET

Catalog Number	12000-000-0011
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Q core medical ltd (manufacturer) is submitting the report on behalf of hospira.Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from usa: leakage of orencia.
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from usa: leakage of orencia.

• Brand Name: AP202 -INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND 0.2 FILTER, NEEDLE Y
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 6515077
• Report Number: 3010293992-2017-00062
• Device Sequence Number: 1642098
• Product Code: FPA
• UDI-Device Identifier: 17290109150427
• UDI-Public: 17290109150427
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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: Other
• Device Catalogue Number: 12000-000-0011
• Device Lot Number: 62-266-5G
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1