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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation however a sample photo was provided; investigation is not yet complete.E1 - additional customer contact number: (b)(6).
Event or Problem Description
The event occurred on unspecified dates between 01-may to 15-may and involved 8" add-on set, bag spike w/clave® additive port, chemolock¿ port, dry spike adapters.The customer reported that the bag spikes leak during patient use while administering cyclophosphamide.The customer stated that the incidents occurred just prior to infusion, after being spiked with administration tubing as well as during infusion.The chemo did come in contact with the patient or healthcare provider.The chemo spill was cleaned up per facility protocol and spill kit was used.There was patient involvement, a delay in therapy but there was no adverse event reported as a consequence of this event.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.Without the return of the sample, a comprehensive review cannot be performed, and a probable cause cannot be determined.Received a photo showing the affected sample.No conclusions could be made from the photo.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 22216096
• Report Number: 9617594-2025-01262
• Device Sequence Number: 12948747
• Product Code: ONB
• UDI-Device Identifier: 00887709080416
• UDI-Public: (01)00887709080416(17)300201(10)14323633
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: 05/20/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• 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: CYCLOPHOSPHAMIDE, MFR UNK.
• Patient Sex: Unknown