MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" (43 CM) APPX 0.48ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MC33309
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a 17¿ (43cm) appx 0.48ml, smallbore ext set w/microclave clear, clamp, luer lock was found to experience no flow of fluid during use with a patient.As per report, the end of the luer lock is faulty in some way causing it to become stuck on the peripherally inserted central catheter (picc) lines and not allow fluid to flow through from the product to other lines.The sample is available for evaluation.There was no patient harm reported.
Additional Manufacturer Narrative
Additional information can be found in b5.No mc33309 product samples, videos, or photographs were returned for investigation.The dhr was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.
Event or Problem Description
Additional information was received that there were five defective devices associated with this complaint.Also, the product fault occurs while in use with a patient and during an attempt to administer normal saline flushes by the registered nurses.
Additional Manufacturer Narrative
D9 - date returned to mfg is 10/23/2024.Received sixteen (16) new, list #mc33309, 17" (43 cm) appx 0.48ml, smallbore ext set w/microclave® clear, clamp, luer lock for inspection.No defects or anomalies noted.The male luer's were tested and meet the iso standard.The microclaves were tested for stickdowns for single activation and multiple activations.There were no stickdowns.The reported complaint could not be replicated or confirmed.Without the return of the used picc line, a comprehensive failure investigation cannot be performed.The device history report (dhr) for lot 13550964 was reviewed and there were no non-conformances found that would have contributed to the reported complaint.

• Brand Name: 17" (43 CM) APPX 0.48ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK
• Common Device Name: STOPCOCK, I.V. SET
• 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: 19903561
• Report Number: 9617594-2024-01071
• Device Sequence Number: 6557217
• Product Code: FMG
• UDI-Device Identifier: 00887709037625
• UDI-Public: (01)00887709037625(17)280201(10)13550964
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• 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,Followup
• Report Date (Section B): 01/07/2025

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: MC33309
• Device Lot Number: 13550964
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 12/11/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/08/2024; 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: UNSPECIFIED FLUID, UNK MFR.
• Patient Sex: Unknown