MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, (RED, GLOW RINGS), 3 CLAMPS, ROTAT; STOPCOCK, I.V. SET

Catalog Number	Z2881
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
Event or Problem Description
It was reported in a medwatch voluntary report with mdr report # mw5152928 stating: ¿bed found to be wet by registered (rn).Upon initial i-trace all connections appropriate and all connections secure.Trifuse adapter found to have a missing valve.¿ the suspected medical device is a 7" smallbore trifuse ext set w/3 microclave®, (red, glow rings), 3 clamps, rotating luer.There was no patient harm reported.

• Brand Name: 7" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, (RED, GLOW RINGS), 3 CLAMPS, ROTAT
• 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: 19244444
• Report Number: 9617594-2024-00544
• Device Sequence Number: 7107851
• Product Code: FMG
• UDI-Device Identifier: 00887709028395
• UDI-Public: (01)00887709028395(17)271001(10)10239796
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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: Z2881
• Device Lot Number: 10239796
• 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: 04/03/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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: UNSPECIFIED FLUID, UNK MFR.
• Patient Sex: Unknown