MAUDE Adverse Event Report: Q CORE MEDICAL LTD. AP431-01 INFUSION SET; ADMINISTRATION SET

Catalog Number	12000-000-0027
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/13/2016
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: "leaking tubing set - tubing leaking from the bottom of chamber.Type of drug: unknown.".

• Brand Name: AP431-01 INFUSION SET
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 6092059
• Report Number: 3010293992-2016-00248
• Device Sequence Number: 13978805
• Product Code: FPA
• UDI-Device Identifier: 17290109150519
• UDI-Public: 17290109150519
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2016

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: 12000-000-0027
• Device Lot Number: UNKNOWN
• Distributor Facility Aware Date: 10/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1