MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 218CM 20 DROP PRIMARY SET W/2 MICROCLAVE®; STOPCOCK, I.V. SET

Catalog Number	012C5024
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An email was received regarding the product 218 cm 20 drop primary set w/2 microclave in which it was reported that leaking reported at the top clave /ysite connection.6 sets leaking from same box, but only from emergency room.None of the other units affected.It was stopped immediately and inservice training done and all other units checked for any other concerns.First sets was replaced and they keep on monitoring if any other sets affected.There was patient involvement and delay in therapy, but no patient harm noted.This is report 1 of 2 for the emergency room event.
Additional Manufacturer Narrative
D4, g4: model number is not sold in the us but similar device is sold under model b9900-217.This product was used for the di, product code, and 501k.The device has been requested for evaluation- it has not been received.The investigation is pending.

• Brand Name: 218CM 20 DROP PRIMARY SET W/2 MICROCLAVE®
• 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: 24740500
• Report Number: 9617594-2026-00329
• Device Sequence Number: 9242687
• Product Code: FMG
• UDI-Device Identifier: 00887709016613
• UDI-Public: 00887709016613
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 012C5024
• Device Lot Number: UNKNOWN
• 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: 03/18/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNSPECIFIED IV FLUID AND PAIN DRUG, MFR UNKNOWN.
• Patient Sex: Unknown