MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5¿ (13 CM) APPX 0.89 ML, BIFUSE EXT SET W/2 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1356
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo was shared by customer, where the set is observed to be connected into a patient, but not really significant leaks or anomalies are noted.The device sample was received at the investigation site and underwent initial intake and decontamination processing.Prior to engineering evaluation, the sample could not be located for further testing.A documented search of applicable handling and storage areas was performed; however, the device could not be recovered.As the physical sample was unavailable for evaluation, testing could not be completed, and a definitive root cause could not be determined.Review of available information, including customer-provided photographs and complaint details, did not identify a conclusive failure mechanism.Should the device be located at a later date, the investigation will be reopened and additional evaluation performed as appropriate.Lot history review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
A photo review was performed, and the set is observed to be connected into a patient, but not really significant leaks or anomalies are noted.Two (2) used device was returned for evaluation and underwent initial intake and decontamination processing.Prior to engineering evaluation, the sample could not be located for further testing.A documented search of applicable handling and storage areas was performed; however, the device could not be recovered.As the physical sample was unavailable for evaluation, testing could not be completed, and a definitive root cause could not be determined.A device history review could not be completed due to the unknown lot number.Updated information in d9 - date returned to mfg: 12/10/2025.Correction in concomitant product.
Event or Problem Description
The event involved a 5¿ (13 cm) appx 0.89 ml, bifuse ext set w/2 clamps, rotating luer and it was reported that the patient had a chemo infuser (elastomeric pump) attached as per protocol for 3 days.The patient came in to remove the ivad (implantable venous access device).The nurse noticed a chemo leak on the patient shirt, the white chemo residual on his skin, and under his dressing.The set was disconnected, examined and flushed the legs of the extension set through the max zero.The max zero were both well attached to the set, not loose was observed.The set leaked, bypassing the max zero cap on the side which had chemo infusing.There was patient involvement, and no patient harm reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as lot number is unknown.

• Brand Name: 5¿ (13 CM) APPX 0.89 ML, BIFUSE EXT SET W/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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23663212
• Report Number: 9617594-2025-02231
• Device Sequence Number: 13330915
• Product Code: FMG
• UDI-Device Identifier: 00887709050365
• UDI-Public: 00887709050365
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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 Catalogue Number: B1356
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2025
• Supplement Date Received by Manufacturer: 01/29/2026; 02/16/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/17/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ELASTOMERIC PUMP, UNK MFR.; FLUOROURACIL, UNK MFR.; MAX ZERO NEEDLELESS CONNECTOR, BD.
• Patient Sex: Unknown