MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3528
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a 30" (76cm) appx 6.3 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, 0.2 micron filter, chemolock¿ w/red cap, hanger where the reporter stated "that 6 hours after the infusion starts, bubbles post filter caused a pump error and when the nurse was addressing the pump error, the line fell out of the bag.The nurse was exposed to 450 ml of etoposide, doxorubicin, vincristine mixture.There were patient involvement and delay in therapy.
Additional Manufacturer Narrative
Received the following: one (1) used.List#: cl3528, 30" (76cm) appx 6.3 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, 0.2 micron filter, chemolock¿ w/red cap, hanger; lot#: 14243855.---> one (1) used.List#: unknown, primary plum set; lot#: 14243855.---> one (1) used.List#: unknown, 0.9% sodium chloride 1000ml bag; lot#: v24j27d.One (1) used.List#: unknown, 0.9% sodium chloride 500ml bag; lot#: unknown.One (1) used.List#: unknown, primary plum set; lot#: unknown.---> one (1) used.List#: unknown, extension set w/ piercing pin; lot#: unknown.---> one (1) used.List#: unknown, 0.9% sodium chloride 50ml bag; lot#: p461764.---> one (1) used.List#: unknown, 0.9% sodium chloride 50ml bag; lot#: 1026991.No visual damages or anomalies were observed.The reported complaint of bubbles in the line could not be confirmed.The returned sample was tested and met product specifications.No bubbles were seen during priming or any leaks observed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA
• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22909568
• Report Number: 9617594-2025-01765
• Device Sequence Number: 9047874
• Product Code: ONB
• UDI-Device Identifier: 00887709057043
• UDI-Public: (01)00887709057043(17)291201(10)14243855
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: CL3528
• Device Lot Number: 14243855
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2024
• 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: DOXORUBICIN, MFR UNKNOWN.; ETOPOSIDE, UNKNOWN MFR.; VINCRISTINE, MFR UNKNOWN.
• Patient Sex: Unknown