MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.67ML EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC3325
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint on the mc3325 could not be confirmed by 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 report (dhr) for lot 14049520 was reviewed and no non conformities were found that would have led to the reported complaint.
Additional Manufacturer Narrative
The device is not available for investigation at this time.A review of the device history record is pending.Additional contact: (b)(6).
Event or Problem Description
The complaint/event involved a 7" (18cm) appx 0.67ml ext set w/remv microclave® clear, clamp, rotating luer.Upon checking on the patient in the am, saline extension luer lock cap was no longer in situ on the iv extension and line was open.It was also noticed on multiple lines that the port has been falling off.It was required to stick the patient again, and this was attempted six times the day before.Community paramedics needed to be called to initiate the same on patient.There was no human harm and there was a delay in therapy.

• Brand Name: 7" (18CM) APPX 0.67ML EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER
• 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: 20411851
• Report Number: 9617594-2024-01402
• Device Sequence Number: 18135033
• Product Code: FMG
• UDI-Device Identifier: 00887709037540
• UDI-Public: (01)00887709037540(17)290601(10)14049520
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: MC3325
• Device Lot Number: 14049520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SALINE SOLUTION, MFR UNK; UNSPECIFIED CATHETER, MFR UNK
• Patient Sex: Unknown