MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS,; STOPCOCK, I.V. SET

Model Number	011-MC3316
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 6" (15cm) appx 0.33ml, smallbore bifuse extension set w/2 microclave¿ clear, 3 clamps, rotating luer.It was reported the microclave was found to be leaking noradrenaline from the screw thread weld on isolated devices.Testing on samples from the same batch found the leaks were not repeatable.The leaks occurred in two devices from two separate batches where no hole, cut, tears or any defected noted.There was no report of harm.This is the second of two events.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
The complaint of leakage on the 011-mc3316 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record for lot 10985830 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS,
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16986454
• Report Number: 9617594-2023-00198
• Device Sequence Number: 12495474
• Product Code: FMG
• UDI-Device Identifier: 00840619043230
• UDI-Public: (01)00840619043230(17)271001(10)10985830
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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 Model Number: 011-MC3316
• Device Catalogue Number: 011-MC3316
• Device Lot Number: 10985830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• 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: NORADRENALINE, UNK MFR
• Patient Sex: Unknown