MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.62 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CLA; STOPCOCK, I.V. SET

Catalog Number	MC330479
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Initial reporter full phone # + (b)(6).Additional contact: (b)(6).The stevens company limited.E3 - corrective actions taken none at this time.E2 - root cause of problem.
Event or Problem Description
The complaint/event involved a 7" (18 cm) appx 0.62 ml, smallbore quadfuse ext set w/4 microclave® clear, 4 clamps, luer lock that was reported to be broken at the quad site.At the time there was only normal saline in the line.It was unknown if there was a patient involved in the event, however there was no report of human harm.
Additional Manufacturer Narrative
The complaint of broken item mc330479 cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history record was reviewed and no non-conformities were found that would have led the reported condition on the complaint.

• Brand Name: 7" (18 CM) APPX 0.62 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CLA
• 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: 18385406
• Report Number: 9617594-2023-01191
• Device Sequence Number: 19825457
• Product Code: FMG
• UDI-Device Identifier: 00887709090200
• UDI-Public: (01)00887709090200(17)280201(10)13551242
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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: MC330479
• Device Lot Number: 13551242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: NORMAL SALINE, MFR UNK
• Patient Sex: Unknown