MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" BIFUSE EXT SET W/CLAVE® CLEAR, 2 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	MC9024
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
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 9" bifuse ext set w/clave® clear, 2 clamps, rotating luer which reportedly leaked small amounts out the top/side of the blue medication connector while the infusion was running chemotherapy from the infusion pump.Chemo spill protocol was followed to clean up the spill.Chemotherapy was reported to have spilled onto the patient's body as all fluid leaked was absorbed into the patient's pants.There was patient involvement, however, there was no harm reported as a consequence of this event.

• Brand Name: 9" BIFUSE EXT SET W/CLAVE® CLEAR, 2 CLAMPS, 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14837330
• Report Number: 9617594-2022-00191
• Device Sequence Number: 4743826
• Product Code: FMG
• UDI-Device Identifier: 00887709067455
• UDI-Public: (01)00887709067455(17)261001(10)5665327
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: 10/01/2026
• Device Model Number: MC9024
• Device Catalogue Number: MC9024
• Device Lot Number: 5665327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALARIS INFUSION PUMP, BD; UNSPECIFIED CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown