MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	MS930
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.The investigation is pending.
Event or Problem Description
The event involved a 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv microclave®, clamp, rotating luer where the customer reported that they had another iv extension set leak from a different box they just opened.The status of the product at the time of event was during injection of radioisotope.The medication leaking at the time of the event is saline.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
Investigation summary: two (2) used list# ms930 and one sodium chloride 0.9% 10ml syringe were returned for evaluation.As received, the clave from the used sample was separated and connected into the syringe and a visible crack on both female luer was observed.Complaint of iv extension set leak can be confirmed or replicated.The probable cause of the crack and subsequent leakage is due to a material issue on a vendor supplied part.A device history record lot review was performed and no discrepancies, anomalies or nonconformances were identified that might lead the condition reported by customer.A corrective and preventative action (capa) plan has been implemented to address the identified issue.The outcome of the capa is currently under evaluation and is not yet finalized.

• Brand Name: 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING
• 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: 21734982
• Report Number: 9617594-2025-00601
• Device Sequence Number: 18342396
• Product Code: FMG
• UDI-Device Identifier: 00887709013971
• UDI-Public: (01)00887709013971(17)291101(10)14218150
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: MS930
• Device Lot Number: 14218150
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: RADIOISOTOPE, MFR UNK.; SALINE, MFR UNK.
• Patient Sex: Unknown