MAUDE Adverse Event Report: Q CORE MEDICAL LTD. AP402-01 HCR - MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE; ADMINISTRATION SET

Catalog Number	12003-000-0027
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2016
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)(4): "upper clave on filtered tubing leaked and/or spiros on secondary set more likely the blue clave.Complaint occurred in jcc chemo suite.Type of set used: filtered tubing.Missed dose: no.Over delivery: no.Under delivery: yes, 60mg of 260.Blood loss: no.Was there blood backflow from iv catheter: no.Was there any air infused: no.What was the length of time the set was in use before the incident occurred? 1hr.Consequences to patient? unknown exact dose patient received since spilled on floor.When did the incident occur: during infusion.Patient involvement: yes.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 (b)(6): "upper clave on filtered tubing leaked.Patient involvement: yes; death/serious injury: no; human harm: no; delay in therapy: no; medical intervention needed: no".

• Brand Name: AP402-01 HCR - MICROBORE YELLOW MARKED WITH 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: 6150523
• Report Number: 3010293992-2016-00277
• Device Sequence Number: 1056823
• Product Code: FPA
• UDI-Device Identifier: 17290109150397
• UDI-Public: 17290109150397
• 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: Nurse
• 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 Caregivers
• Device Catalogue Number: 12003-000-0027
• Device Lot Number: 622565G
• Distributor Facility Aware Date: 11/11/2016
• 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: 12/07/2016
• 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