MAUDE Adverse Event Report: Q CORE MEDICAL AP431-01 HCR- INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER,BACK CHECK VALVE,

Catalog Number	12000-000-0027-00
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
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 (b)(6): "reported leaking at distal tip where spiros connects to clave and clave connector connects to picc.Patient involvement: yes.Death/serious injury: no.Human harm: no.Delay in therapy: yes.Medical intervention needed: no.".
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from (b)(6): "reported leaking at distal tip where spiros connects to clave and clave connector connects to picc.Patient involvement: yes; death/serious injury: no; human harm: no; delay in therapy: yes; medical intervention needed: no".

• Brand Name: AP431-01 HCR- INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER,BACK CHECK VALVE,
• Common Device Name: INFUSION SET
• Manufacturer (Section D): Q CORE MEDICAL; yad harutzim 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 6176747
• Report Number: 3010293992-2016-00293
• Device Sequence Number: 19060909
• Product Code: FPA
• UDI-Device Identifier: 17290109150519
• UDI-Public: 17290109150519
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2017

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: 12000-000-0027-00
• Device Lot Number: 581465G
• 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: 12/15/2016
• Supplement Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1