MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOCLAVE¿; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3955
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of cracks on item ch3955 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The dhr review couldn't be performed due to the lot number for this complaint was unknown.
Event or Problem Description
The reported complaint involved a chemoclave¿ bag spike with additive port, chemoclave¿.The reporter originally stated that a spiros broke while a nurse was handling icu medical product prior to giving an unspecified chemotherapy drug to the patient and the chemo spilled all over the nurse.Additional information was subsequently provided by the customer referring to the possible list number of ch3955.There was no other clinical consequence to the nurse or the patient reported.

• Brand Name: CHEMOCLAVE¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOCLAVE¿
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22323139
• Report Number: 9617594-2025-01334
• Device Sequence Number: 9023224
• Product Code: FPA
• UDI-Device Identifier: 00887709098305
• UDI-Public: 00887709098305
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• 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
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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: CH3955
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK.; UNSPECIFIED SPIROS DEVICE, MFR ICU MEDICAL.
• Patient Sex: Unknown