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 Code	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
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 7" smallbore trifuse ext set w/remv 3 microclave® clear (glow, purple rings), 3 clamps, rotating luer that reportedly leaked an unspecified fluid/infusate at the base of the microclave during patient use.Initially the facility suspected that the microclave leakage was coming from the connection to the 1f vygon picc.They also use other sizes of picc but primarily the 1f.Upon further review, the leakage was observed from the base of the microclave, even on the trifuse extension set.The event date is ongoing approximately for one calendar year.There was no human harm and it was unknown if there was any delay in therapy.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Recieved one (1) used list# mc33917, 7" smallbore trifuse ext set w/remv 3 microclave® clear (glow, purple rings), 3 clamps, rotating luer.As received, no physical damage or other anomalies observed.Product was tested and meet specifications.Leak tested as received, unable to confirm customer complaint of leaking at the base of the microclave.The possible lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 20767735
• Report Number: 9617594-2024-01680
• Device Sequence Number: 9302916
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 12/10/2024
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 PICC, MFR VYGON; UNSPECIFIED FLUID/INFUSATE, MFR UNK; UNSPECIFIED PICC LINES OF VARYING SIZES, MFR UNK
• Patient Sex: Unknown