MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX. 0.36 ML SMALLBORE EXTSETW/MICROCLAVE® CLEAR, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MC330363
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
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 complaint/event occurred on an unspecified date and involved a 60" (152 cm) appx.0.36 ml, smallbore ext set w/microclave® clear, clamp, luer lock.The report stated that there is white film that they see inside the clave and they have seen this few times now.There was no report of human harm.
Additional Manufacturer Narrative
One photo was shared by the customer where a unknown white film is observed inside the shuntless microclave, no additional damage or anomalies are observed.One used.List #mc330363 was returned for evaluation.As received an unknown solution inside the sample was observed.No additional damage beside the mentioned was observed.The sample was tested as procedure and no internal / external leak was observed.The shuntless microclave was dissembled, and unknown shite solution was observed inside the sample and an intermittent of lubrication in the spike was observed.No additional damage or anomalies complaint of white film inside the clave can be confirmed.There probable cause of the solution is due to unknown solution that got dry after use, how, when or where this solution got outside the seal is unknown.The probable cause of the intermittent of lubrication in spike is due to an error during lubrication process in manufacturing.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 60" (152 CM) APPX. 0.36 ML SMALLBORE EXTSETW/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: 20423489
• Report Number: 9617594-2024-01425
• Device Sequence Number: 8402328
• Product Code: FMG
• UDI-Device Identifier: 00887709085329
• UDI-Public: 00887709085329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 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: MC330363
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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