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	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv microclave®, clamp, rotating luer where it was reported that the product is leaking.The device leaked at the clave connector.The event occurred during an iv being set for a patient on different occasions and different boxes.There was patent involvement and no patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation; investigation is pending.
Additional Manufacturer Narrative
Two sealed boxes of fifty (50) each.List #ms930, 7.5" were returned for evaluation.As received the whole samples were visually inspected and no loose, missing or separated clave was observed.No mating device was returned for evaluation.Based on the binomial stages sampling to represent the lot population 35 samples were taken, each sample was tested as per procedure and no leaks or anomalies were observed.Complaint of leaks was not able to be confirmed or replicated.The lot history was reviewed and 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: 21191048
• Report Number: 9617594-2025-00144
• Device Sequence Number: 3517764
• Product Code: FMG
• UDI-Device Identifier: 00887709013971
• UDI-Public: (01)00887709013971(17)290901(10)14137251
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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: 14137251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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