MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number	MC33098
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received with regards to a 4" (10 cm) appx 0.40 ml, smallbore trifuse ext set w/3 microclave¿ clear, 3 clamps, rotating luer tore during use.It was reported that "this hospital has reported several instances of our item mc33150 with the silicone stuck down.Most of our product complaints investigations concluded that the reported issue was due to an incompatible mating device.However, our device mc33098 is most commonly connected to mc33150.Despite several iv assessments to test all product in the storeroom for incompatibility with microclave, we have not been able to identify any incompatible sets that could be contributing to the issue.We¿d like for you to test the male luer of mc33098 for any anomalies that could be contributing to tears and stickdown on the connecting microclave." the event date unknown.Event occurred unknown.There was patient involvement, no patient harm.The problem has occurred from november 2023-present.There have been multiple events, but the customer did not record the dates.There was a small delay in therapy to replace the defective product.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2024 has been used as a placeholder.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The device was received for evaluation.As received, no physical damage or other anomalies observed.Tested the male luer, also each of the three microclaves were tested and no stick downs or other anomalies observed.Unable to confirm customer complaint of seeing stick down conditions.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAM
• 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: 20767053
• Report Number: 9617594-2024-01675
• Device Sequence Number: 18480757
• Product Code: FMG
• UDI-Device Identifier: 00887709037366
• UDI-Public: (01)00887709037366(17)290401(10)13962779
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/30/2024

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: MC33098
• Device Lot Number: 13962779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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