MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC33129
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
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.
Event or Problem Description
A complaint was received with regard to a 4" smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer that tore during use.The reporter stated 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 likely due to an incompatible mating device.However, our device mc33129 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 mc33129 for any anomalies that could be contributing to tears and stickdown on the connecting microclave." the event date unknown.There was patient involvement, no patient harm.
Additional Manufacturer Narrative
One used.List #mc33129 was returned for evaluation.As received no physical damage or anomalies are observed.The male luer was measured and meets iso specifications.No mating device was returned for evaluation.Unable to confirm the customer complaint of "the male luer causing stick down and cracking and leaking." the lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 4" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER
• 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: 20767056
• Report Number: 9617594-2024-01676
• Device Sequence Number: 18480758
• Product Code: FMG
• UDI-Device Identifier: 00887709037427
• UDI-Public: (01)00887709037427(17)290401(10)13952565
• 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: MC33129
• Device Lot Number: 13952565
• 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: 12/04/2024
• 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: 04/05/2024
• 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