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	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation- the investigation is pending.
Event or Problem Description
The event occurred on an unknown date involving a clave¿ neutral connector where the reporter stated that there is leaking (blood and or fluids) at the connection between the iv catheter and the blue clave.They are finding complaints in ct scanner with contrast dye is leaking.Due to patient safety, they cannot use the 60 cases due to this serious problem.There was unknown patient involvement and no adverse event.
Additional Manufacturer Narrative
Two (2) new list# b3300, clave¿ neutral connector and four (4) new list# unknown, bd insyte autoguard 24 ga x 0.75 were returned for evaluation.As received no physical damage or anomalies were observed.The returned new claves were opened and connected with the returned catheters no disconnection, issues or anomalies were observed.The claves were tested, and no leaks were confirmed.The male and female luers were measured finding within specification.Complaint of leaks at the connection cannot be confirmed or replicated.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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, IL 60045 ; 2247062300
• MDR Report Key: 20846107
• Report Number: 9617594-2024-01733
• Device Sequence Number: 17076229
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: (01)00840619045593(17)290501(10)14029184
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 14029184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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: CT SCANNER WITH CONTRAST DYE, MFR UNK.; IV CATHETER, MFR UNK.
• Patient Sex: Unknown