MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS® W/RED CAP, VENTED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3033
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded.Therefore, a comprehensive investigation was unable to be performed based on the the information that has been provided and a probable cause cannot be identified.
Event or Problem Description
The event involved bifuse tubing that leaked drops of an unknown chemotherapy drug and made contact with the patient and caregivers.The device was changed and no further problems were encountered.There was patient involvement and a delay in therapy, however no reported medical or surgical intervention.

• Brand Name: 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS® W/RED CAP, VENTED CAP
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 8391920
• Report Number: 9617594-2019-00052
• Device Sequence Number: 11120749
• Product Code: ONB
• UDI-Device Identifier: 00840619024109
• UDI-Public: (01)00840619024109(17)230401(10)3659325
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: 04/01/2023
• Device Catalogue Number: CH3033
• Device Lot Number: 3659325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR