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	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one (1) used b3300 clave and one (1) used 3 ml syringe for inspection.As received, the slit propagated through the top surface of the seal.The clave was leak tested and found to be leaking.The syringe was measured and found to be compatible with the clave.The reported complaint can be confirmed.The probable cause is due to access with an incompatible mating device.The dfu states: "the clave connector is compatible with luers with an internal diameter (id) between.062 inch and.110 inch." although the returned mating device was compatible, it is unknown what other devices were used to access the clave.A device history review (dhr) lot# review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
It was reported that a clave¿ neutral connector generated a leak during patient use.It was reported, "nad on picc medication tubing started leaking.K+ nder + zosyn potentially lost in the process.Md required giving new dose of zosyn to make up for missed/leaking dose".There was no patient harm reported.

• 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: 21280186
• Report Number: 9617594-2025-00207
• Device Sequence Number: 12753015
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: 00840619045593
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/30/2025
• 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: ZOSYN, UNK MFR
• Patient Sex: Unknown