MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM.

Catalog Number	CLH-12
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation; a lot history review should be conducted.
Event or Problem Description
The event was reported via user facility mandatory medwatch report number (b)(4).The event occurred 2 times on an unspecified date(s) in october - oct 1st, 2025, is used as placeholder.The event involved an 8" add-on set, bag spike w/clave® additive port, chemolock¿ port, dry spike adapter and the customer stated that inotuzumab was picked up from pharmacy with chemo spike adapter in place/spiked into chemo bag.The chemo spike adapter had a white dry spike adapter and a blue chemo lock upside down.The healthcare professional spiked the white spike adapter but there was some resistance when spiking the white spike adapter.When she went to administer the inotuzumab, the nurse disconnected the spiros from the blue microclave/side-port, and the medication started to quickly leak out of the blue microclave/side port.The second dose was primed with an adapter that had the downward facing chemo lock, and a white spike adapter pigtail.The chemo lock was utilized to prime the medication.When she went to assess the infusion upon returning, she noticed that there was a large drop of medication coming out of the blue microclave/side-port, however, it was not actively dripping, as the previous dose had been.She noted that the microclave looked like it was still inverted in the "engaged" position.When she attached saline flush to the blue microclave/side port, and then detached after flushing, she noted that the microclave disengaged.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.The lot history was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.Updated information in d9 and e3.

• Brand Name: 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAP
• 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: 23609516
• Report Number: 9617594-2025-02196
• Device Sequence Number: 18456409
• Product Code: ONB
• UDI-Device Identifier: 00887709080416
• UDI-Public: (01)00887709080416(17)300201(10)14323633
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: CLH-12
• Device Lot Number: 14323633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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: INOTUZUMA, MFR UNK
• Patient Age: 22 YR
• Patient Sex: Male