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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation- 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 it was stated in the report that the valve does not sit tightly on the tubing and can become dislodged.The event occurred during infusion.There was patient involvement, no patient harm and there was no delay in therapy, but tech had to be sent to the er for blood exposure.
Additional Manufacturer Narrative
One (1) sample photo was provided showing the details in the packaging of the product.Received fifteen (15) new list# ms930, 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv clave¿, clamp, rotating luer.As received, no physical damage or other anomalies were observed.Samples were tested for correct dimensions per iso standards and all met specifications.Cannot confirm customer complaint of "the valve does not sit tightly on the tubing and can become dislodged".The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21128906
• Report Number: 9617594-2025-00059
• Device Sequence Number: 17848862
• Product Code: FMG
• UDI-Device Identifier: 00887709013971
• UDI-Public: (01)00887709013971(17)290901(10)14073404
• Combination Product (Y/N): N
• 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): 02/12/2025

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: 14137236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Patient Sex: Unknown