MAUDE Adverse Event Report: Q CORE MEDICAL LTD. AP331-01 - NON PVC UV RESISTANT MICROBORE WITH VENTED/NON-VENTED SPIKE; ADMINISTRATION SET

Catalog Number	12007-000-0005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from usa: "tubing leaking at distal end.Patient involvement: yes.".
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from usa: administration set leakage.

• Brand Name: AP331-01 - NON PVC UV RESISTANT MICROBORE WITH VENTED/NON-VENTED SPIKE
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 6416158
• Report Number: 3010293992-2017-00030
• Device Sequence Number: 1013238
• Product Code: FPA
• UDI-Device Identifier: 17290109150427
• UDI-Public: 17290109150427
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/02/2017

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: Nurse
• Device Catalogue Number: 12007-000-0005
• Device Lot Number: 62-266-5G
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2017
• 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