MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NONVENTED PLUM SET 1'S; ADMINISTRATION SET

Model Number	1187912
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned to the manufacturer for further evaluation but has not yet been received.
Event or Problem Description
It was reported that a phyxol infusion was started on (b)(6) 2019 and on (b)(6) 2019 the device being used was found leaking the medication with 10 ml of drug left in the bag.Traces of the medication leak were found on the patient¿s clothing.It was reported that the patient found the bed rail wet on the morning of (b)(6) 2019.There was no harm to the patient reported.No additional information is available.
Additional Manufacturer Narrative
The complaint of leakage on 118790412 could not be confirmed by the investigation.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.A batch record review was performed to lot# 3864774 and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.

• Brand Name: NONVENTED PLUM SET 1'S
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8927258
• Report Number: 9615050-2019-00363
• Device Sequence Number: 18892646
• Product Code: FRN
• UDI-Device Identifier: 10887787009023
• UDI-Public: (01)10887787009023(17)211101(10)3864774
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K982159
• 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): 07/31/2019

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: 11/01/2021
• Device Model Number: 1187912
• Device Catalogue Number: 118790412
• Device Lot Number: 3864774
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/06/2019
• 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: PHYXOL UKN MFR; PHYXOL UKN MFR