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

Catalog Number	12000-000-0027
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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: "per clinical department, the issue is slit on tubing at slider clamp area- 12000-000-0027- ap431-01 - infusion set with vented/non-vented drip chamber,back check valve, 2 needleless y-site injuries or adverse event: no; item: (b)(4); quantity affected: 1 each; serial/lot number: n/a; po #: (b)(4); are any samples available for return? no.Thirty (30) cc leaks from tubing to floor in pt room, no human harmed, splash of chemo coloring unto rn shoe.Death/serious injury: no, human harm: no, delay in therapy: no, medical intervention needed: no.".
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from usa: administration set leakage of chemotherapy.

• Brand Name: AP431-01
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 6165412
• Report Number: 3010293992-2016-00282
• Device Sequence Number: 279890
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

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: 12000-000-0027
• Distributor Facility Aware Date: 11/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2016
• Supplement Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1