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

Catalog Number	011-C3300
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a clave¿ neutral connector where the customer reported that the device was unable to flow from the filter during patient infusion of infliximab, causing delay in therapy.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no delay in critical therapy no adverse operator consequences , no med/surg intervention required and no involved device available to be tested.The device was changed out/replaced with no further problems encountered.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.Additional contact information (b)(6).
Additional Manufacturer Narrative
One used list #011-c3300 and one used unknown, extension set w/ filter, were returned for evaluation on 4/22/2024.As received some infliximab solution residuals was observed the returned microclave.Each of the returned set was tested separated at gravity pressure and no flow restriction were observed.Complaint of no flow / can't prime/ difficult to prime cannot be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: MICROCLAVE® 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: 18943546
• Report Number: 9617594-2024-00301
• Device Sequence Number: 18237927
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)280701(10)13700453
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K970855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2024

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: 011-C3300
• Device Lot Number: 13700453
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: INFLIXIMAB, MFR UNK
• Patient Sex: Unknown