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

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 303278071
• Report Number: 9617594-2022-00191
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709067455
• UDI-Public: (01)00887709067455(17)261001(10)5665327
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALARIS INFUSION PUMP, BD; UNSPECIFIED CHEMOTHERAPY, MFR UNK