MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, 2 CLAMPS, ROT; STOPCOCK, I.V. SET

Model Number	011-C3322
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
The event involved a 5" (13 cm) appx 0.33 ml, smallbore bifuse ext set w/2 microclave®, 2 clamps, rotating luer.The customer reported that there was leakage of chemotherapy medication on the unused part of the bifuse connector.The bifuse (with 2 clave) was used as connected to the patient¿s iv line since the patient would have an essay pump chemotherapy infusion that would be brought to the patient's home.The patient was discharged subsequently that day after his iv line was checked thoroughly and carefully for patency and leaks.Later that day, the patient went back to the hospital after observing the medication leakage.The hospital¿s emergency department managed the medication leakage incident thereafter.The event occurred during the procedure/infusion.There was patient involvement and no human harm reported.

• Brand Name: 5" (13 CM) APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, 2 CLAMPS, ROT
• 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: 15428515
• Report Number: 9617594-2022-00270
• Device Sequence Number: 4750166
• Product Code: FMG
• UDI-Device Identifier: 00840619001742
• UDI-Public: (01)00840619001742(17)270101(10)5789409
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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 Model Number: 011-C3322
• Device Catalogue Number: 011-C3322
• Device Lot Number: 5789409
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: UNSPECIFIED AMBULATORY INFUSION PUMP, MFR UNK; UNSPECIFIED CHEMOTHERAPY (MFR UNK)
• Patient Age: 80 YR
• Patient Sex: Male