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

Catalog Number	B3300
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microclave® neutral connector exhibited a crack and leak.The initial reporter stated that they have received multiple reports of item b3300 leaking and/or cracking while being used.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2024 has been used as a placeholder.D4 and h4 the lot#, expiration date, and manufacture date are unknown.The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
Additional Manufacturer Narrative
The complaint could not be confirmed by the investigation.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 a cause cannot be determined.The device history review (dhr) was reviewed and no nonconformities were found that would have led to the reported complaint.
Additional Manufacturer Narrative
Additional information d4 section.

• Brand Name: MICROCLAVE® 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: 20995848
• Report Number: 9617594-2024-01844
• Device Sequence Number: 20846512
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: (01)00840619045593(17)290201(10)13909680
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/01/2025

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: 13909680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 12/02/2024
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/30/2025; 02/03/2025
• 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
• Patient Sex: Unknown