MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/5" (13 CM) ADD-ON SET W/CHEMOLOCK¿ ADDITIVE PORT, VENTED CAP; CHE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3538
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved an oncology kit add-on set w/ chemolock additive port, vented cap chemolock spinning spiros where the customer reported that the spiros detached from a primary line during drug administration (taxol).The report also stated that a minimal spill and leak was noticed immediately.There was no report of patient harm as a consequence of this event.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
Additional information in section b5.D9 - date returned to mfr: 3/12/2026 received one (1) used spiros from the cl3538 oncology kit for inspection.The spin feature mechanism was activated and spinning freely as received.No spline damage or shear tab anomalies were observed.The spiros was functionally tested.The spiros met performance expectations.The reported complaint can be confirmed due to the spiros being returned separated with the spin feature mechanism activated.The probable cause is unknown.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
New information was received stating: the customer also stated that the patient had about 15 minutes left in the taxol infusion and reported the spiros cap disconnected.There were two drops on her pants and some drops on her hands.Patient washed her hands with soap and water.Her skin was intact, no redness or irritation when she left the facility later that day.There were drops on the floor as well.There was a delay in therapy, since the taxol was stopped while the cleanup of the spill could occur.The patient was able to finish the rest of the infusion.The reporter also added that they followed up with her the next day and patient reported no negative symptoms to her hands.They had seen her several times since the incident and no harm was brought to her hands.There was patient involvement and no harm.

• Brand Name: ONCOLOGY KIT W/5" (13 CM) ADD-ON SET W/CHEMOLOCK¿ ADDITIVE PORT, VENTED CAP; CHE
• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24522939
• Report Number: 9617594-2026-00226
• Device Sequence Number: 15883709
• Product Code: ONB
• UDI-Device Identifier: 00887709071902
• UDI-Public: (01)00887709071902(17)300501(10)14400207
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (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): 04/23/2026

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: CL3538
• Device Lot Number: 14400207
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2025
• 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: TAXOL, MFR UNK
• Patient Sex: Unknown