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 Codes	Fluid/Blood Leak (1250); Separation Problem (4043)
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 was leaking (blood and or fluids) at the connection between the iv catheter and the blue clave.Additionally, the customer stated that the problem was using the bd insyte autoguard with the icu medical b3300.The leak was taking place right at the connection of both once twisted together.The customer also stated that it was very difficult to turn (twist) the b3300 into the autoguard threads and once in, it is almost impossible to remove it like it is stuck.They are finding complaints in cancer care with chemo leaking.Due to patient safety, they cannot use the 60 cases due to this serious problem.There was unknown patient involvement but no patient harm.
Additional Manufacturer Narrative
Received the following: one (1) used list# b3300, clave¿ neutral connector; lot# 14029184.One (1) used list# unknown, catheter; lot# unknown.Two (2) new list# b3300, clave¿ neutral connector; lot# 14029184.Two (2) new list# unknown, bd insyte autoguard 24 ga x 0.75 in; lot# 4080062.Two (2) new list# unknown, bd insyte autoguard 22 ga x 1.00 in; lot# 4101330.No damages or anomalies were observed on any of the samples.The reported complaint of a leak could not be confirmed.The catheters and male luers were found to be iso compliant, easily removed, and no leaks were observed during testing on the used or new samples.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: 20846133
• Report Number: 9617594-2024-01731
• Device Sequence Number: 3771197
• 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): 01/23/2025

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: 12/30/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown