MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUMSET-W/2 CLAVE 1'S; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1203012
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not been received.
Event or Problem Description
The event occurred on an unspecified date and involved a plumset that was noted to have chemo drug that leaked on the air vent.No additional details were provided.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and there were no nonconformance's that would have contributed to the reported complaint.

• Brand Name: PLUMSET-W/2 CLAVE 1'S
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8894722
• Report Number: 9615050-2019-00352
• Device Sequence Number: 1628151
• Product Code: FPA
• UDI-Device Identifier: 10887787005193
• UDI-Public: (01)10887787005193(17)220101(10)3894652
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 1203012
• Device Catalogue Number: 120300412
• Device Lot Number: 3894652
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPEC CHEMOTHERAPY