MAUDE Adverse Event Report: Q CORE MEDICAL LTD. AP231-01 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VALVE, 2; ADMINISTRATION SET

Catalog Number	12003-000-0027-00
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Q core medical ltd (manufacturer) is submitting the report on behalf of icu medical.Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from usa: administration set leakage of nivolumab.

• Brand Name: AP231-01 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VALVE, 2
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 6889296
• Report Number: 3010293992-2017-00147
• Device Sequence Number: 13482121
• Product Code: FPA
• UDI-Device Identifier: 17290109150519
• UDI-Public: 17290109150519
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/24/2017

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: Other
• Device Catalogue Number: 12003-000-0027-00
• Device Lot Number: 690055G
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1