MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3187
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An event occurred involving a 15" (38 cm) appx 5.2 ml, bifuse add-on set w/bag spike, spiros¿, 3 clamps (blue, red, white), dry spike adapter that reportedly leaked cisplatin during infusion.There was no bleed back reported.There was patient involvement, no patient harm/adverse event and no delay in critical therapy as a result of this event.Only one (1) sample device was affected.
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.E1 - this complaint was received through: (b)(6).
Additional Manufacturer Narrative
Investigation summary: a photo was returned by the customer showing the set with the bond area below the spiros as the area of leakage.No leakage observed in the photo.Received one (1) used ch3187 connected to one (1) used list# unknown plum set for inspection.No defects or anomalies noted.No mating devices were returned for inspection.The ch3187 and plum set were leak tested per product specifications.There was no leakage.The reported complaint was unable to be replicated or confirmed.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE,
• 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: 22709610
• Report Number: 9617594-2025-01597
• Device Sequence Number: 18581867
• Product Code: ONB
• UDI-Device Identifier: 00840619025335
• UDI-Public: (01)00840619025335(17)300101(10)14287865
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: CH3187
• Device Lot Number: 14287865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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: CISPLATIN, MFR UNKNOWN.
• Patient Sex: Unknown