MAUDE Adverse Event Report: Q CORE MEDICAL LTD. AP210-01 MICROBORE WITH NON-VENTED SPIKE AND 1.2μ FILTER; ADMINISTRATION SET

Lot Number	12003-000-0030
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from usa: "chemo (5fu) leaked out of the filter.Patient involvement: yes.Human harm: no.Delay in therapy: yes.Medical intervention needed: no.".

• Brand Name: AP210-01 MICROBORE WITH NON-VENTED SPIKE AND 1.2μ FILTER
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 6252830
• Report Number: 3010293992-2016-00322
• Device Sequence Number: 874090
• Product Code: FPA
• UDI-Device Identifier: 17290109150335
• UDI-Public: 17290109150335
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 01/15/2017

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 Lot Number: 12003-000-0030
• Distributor Facility Aware Date: 12/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1