MAUDE Adverse Event Report: ICU MEDICAL, INC. BAG SPIKE ADAPTER

Model Number	CL3534
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint received regarding one cl3534.Report states: there was a chemotherapy leak at the connection of the product identified above and the secondary set, cl3520.No adverse patient consequences reported.

• Brand Name: BAG SPIKE ADAPTER
• Common Device Name: BAG SPIKE
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city 84601
• MDR Report Key: 6813144
• Report Number: 2025816-2017-00185
• Device Sequence Number: 10803674
• Product Code: ONB
• UDI-Device Identifier: 00887709057067
• UDI-Public: 887709057067
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/23/2017

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 Model Number: CL3534
• Device Catalogue Number: CL3534
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1