MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, NANOCLAVE; STOPCOCK, I.V. SET

Catalog Number	A1003
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The incident involved a 6" (15 cm) appx 0.24 ml, smallbore ext set w/microclave® clear, clamp, nanoclave® t-connector, rotating luer.It was reported that the clave valve disengaged from the mechanism.The event occurred when changing fluids and was noticed immediately upon connecting.It was then removed and a second product was used.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
The complaint of clave valve disengagement (the silicone seal protruding from the top) can be confirmed on the returned one (1) used.List #a1003, 6" (15 cm) appx 0.24 ml, smallbore ext set w/microclave® clear, clamp, nanoclave® t-connector, rotating luer; lot #13617560.As received the silicone seal was protruding from the top of the nanoclave.No other damages or anomalies were observed.The probable cause of the protruding seal is due to over pressurizing during use.The directions for use (dfu) states: "prior to pressurizing, activate the slide clamp and give the pressure infusion through the clave/microclave y site." the lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6" (15 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, NANOCLAVE
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17491221
• Report Number: 9617594-2023-00508
• Device Sequence Number: 7252780
• Product Code: FMG
• UDI-Device Identifier: 00887709051034
• UDI-Public: (01)00887709051034(17)280401(10)13617560
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: A1003
• Device Lot Number: 13617560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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
• Patient Sex: Unknown