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	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available 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 the reporter stated that after she attached the item to flush out, the iv was leaking from the end that she attached the syringe.The event happened during use on a patient.Saline was leaking at the time of the incident and blood flowed down towards the end when the syringe was attached.This issue occurred when flushing the iv ext set.There was no saline solution bag involved.There was patient involvement but no adverse events.The number of product issues occurred was twice.
Additional Manufacturer Narrative
Five new list# ms930, smallbore ext sets were received and visually inspected.As received no damage or anomalies were identified.No mating devices were returned.The five samples were leak tested and no leakage was observed from any location on the returned sets.The reported complaint of leakage could not be confirmed.The device history for lot number 14045657 was reviewed and there were no non-conformances found that would have contributed to the reported complaint.Updated information in d9.

• 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: 20670034
• Report Number: 9617594-2024-01595
• Device Sequence Number: 7238892
• Product Code: FMG
• UDI-Device Identifier: 00887709013971
• UDI-Public: (01)00887709013971(17)290601(10)14045657
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 14045657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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: SALINE, MFR UNK
• Patient Sex: Unknown