MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 0.48 ML, SMALLBORE EXTENSION SET; STOPCOCK, I.V. SET

Catalog Number	MS403
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
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 14" (36 cm) appx 0.48 ml, smallbore extension set where the reporter stated that there have been several reports of the extension set leaking.A crack was seen where the extension set is connected to the end cap.The occurrence is 4.The status of the product at the time of event was used on a patient.The medication leaking at the time of event was milrinone.There was patient involvement and unknown adverse events.There was delay in therapy.
Additional Manufacturer Narrative
One used device was received for evaluation.A crack was found on the female luer opposite side of the gate.The set was leak tested per product specifications.The reported complaint of leakage can be confirmed due to the crack on the female luer.The probable cause of the crack is due to a material issue on a vendor supplied part.Corrective and preventative actions are in process.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 14" (36 CM) APPX 0.48 ML, SMALLBORE EXTENSION SET
• 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: 21414337
• Report Number: 9617594-2025-00320
• Device Sequence Number: 12815773
• Product Code: FMG
• UDI-Device Identifier: 00887709000896
• UDI-Public: 00887709000896
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: MS403
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: MILRINONE, MFR UNK
• Patient Sex: Unknown