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

Catalog Number	MC33917
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
Event or Problem Description
The event occurred on various days and involved a 7" smallbore trifuse ext set w/remv 3 microclave® lear (glow, purple rings), 3 clamps, rotating luer where it was reported that in the past two weeks, they had instances of cracked microclaves reported in the neonatal intensive care unit (nicu).Initially, there was concern that the peripherally inserted central catheter (picc) lines were causing the issue, but current feedback points toward the microclaves themselves as the source.There were complaints of cracking at the base of the microclaves.Initially they suspected the cracking of the microclave was coming from the connecting to the 1f vygon picc.They use other sizes of picc but primarily the 1f.It was also stated that they teased this out as they see the leaking from the base of the microclave even on the trifuse extension set.The event date is ongoing approximately for one calendar year.Status was during patient use.There was patient involvement, no human harm and unknown in delay in therapy.This captures 1 of 2 occurrences.
Additional Manufacturer Narrative
The device for the second occurrence was not returned for evaluation.Without the return of the sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A dhr review could not be conducted because no lot number was identified.Corrected information can be found in h6 medical device problem codes.

• Brand Name: 7" SMALLBORE TRIFUSE EXT SET W/REMV 3 MICROCLAVE® CLEAR (GLOW, PURPLE RINGS), 3
• 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: 20754448
• Report Number: 9617594-2024-01656
• Device Sequence Number: 15769152
• Product Code: FMG
• UDI-Device Identifier: 00887709071605
• UDI-Public: 00887709071605
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/17/2025

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: MC33917
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• 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: 12/23/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 1F VYGON PICC; TRIFUSE EXTENSION SET, UNK MFR
• Patient Sex: Unknown