MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	B3300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
A clave¿ neutral connector was reportedly leaking bivalirudin at the connection of the tubing and the clave at the pump.The leak dripped onto the syringe pump during administration.The nurse immediately retrieved the new bivalirudin from the refrigerator and replaced the medication and microtubing.The provider was immediately notified due to falling ptts.There was no adverse event and delay in therapy that would lead to patient harm if not caught by staff.
Additional Manufacturer Narrative
Device received on 6/26/2025.Investigation summary.Received one (1) used list# unknown, 50ml syringe; lot# unknown one (1) used list# b3300, clave¿ neutral connector; lot# unknown one (1) used list# unknown, ext set; lot# unknown.A crack was observed on the female luer of the tubing set.The reported complaint of a leak could be confirmed.The returned b3300 was tested and met product specifications.A crack was observed on the unknown extension set.The probable cause for the crack cannot be determined due to not being an icu medical product.A device history record review could not be conducted because no lot number(s) was/were identified.

• Brand Name: CLAVE¿ NEUTRAL CONNECTOR
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest 60045 ; 2247062300
• MDR Report Key: 22507919
• Report Number: 9617594-2025-01451
• Device Sequence Number: 9303895
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: 00840619045593
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K100434
• 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): 09/15/2025

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: B3300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: BIVALRUDIN, MFR UNK.; UNSPECIFIED TUBING SET, MFR UNK.
• Patient Sex: Unknown