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	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received seventeen (17) new list# clh-12, 8" add-on set, bag spike w/clave® additive port, chemolock¿ port, dry spike adapter: lot# 14323633.No visual damages or anomalies were observed.While the complaint of a leak could not be replicated during testing, the reported complaint of a leak could be confirmed from a lot history review.The probable cause of the leak is a molding error in salt lake city.A device history review (dhr) was performed and found to use the same tool as previous complaints with the same issue.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.Additional reporter: (b)(6).
Event or Problem Description
The event occurred on an unspecified date and involved a 8" add-on set, bag spike w/clave® additive port, chemolock¿ port, dry spike adapter where it was reported the device leaked from the blue end when used.There was unknown patient involvement and unknown patient harm and no adverse event.

• 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: 22078158
• Report Number: 9617594-2025-01093
• Device Sequence Number: 9337998
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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
• Patient Sex: Unknown