MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	MC9013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The event involved a 14¿ ext set w/0.2 micron filter, clave ¿ clear, clamp, rotating luer where a leak of chemotherapy was noted.It was reported that the final chemotherapy, cisplatin, (of dicep chemotherapy) had just been started at 659 ml an hour; the patient complained of feeling something wet on her legs and on her gown.It was also reported that the infusion was stopped, and a leak of chemotherapy could be seen at the side of a 0.2 micron filter.A new filter was used for the remainder of the infusion and the patient¿s skin was washed and her clothing was changed.There was no blood loss or bleed back reported.There were no obvious defected noted on the tubing set.There was patient involvement, and a report of unprotected chemotherapy exposure to the healthcare provider or the patient; but no apparent harm was reported.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10859995
• Report Number: 9617594-2020-00498
• Device Sequence Number: 3793460
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: (01)00887709039391(17)250601(10)4896097
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 06/01/2025
• Device Model Number: MC9013
• Device Catalogue Number: MC9013
• Device Lot Number: 4896097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1