MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC; STOPCOCK, I.V. SET

Catalog Number	MC33687
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one (1) used mc33687 smallbore trifuse extension set w/3 microclave and one (1) used list #unknown microclave.The list# unknown microclave head was broken off in the male luer of the mc33687.A white powdery substance was present, typical of dried up infusate.The reported complaint can be confirmed.The probable cause is due to environmental stress along with an unintentional bending force during use.Lot history review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not complete.
Event or Problem Description
The event involved a 4" (10 cm) appx 0.68 ml, smallbore trifuse ext set w/3 microclave® clear, 2 check valve, 3 clamps (2 white, red), rotating luer where the customer reported that they found cap/trifuse cracked and broken off during patient infusion in the picu at 19:30h.The customer reported that the bed was wet on first assessment; they immediately clamped the line, changed the cap in a sterile manner and cleansed for an extra 15seconds with alcohol.The lines were changed and reconnected.The customer stated that the cap appeared to have white areas as if precipitate had been in the cap.They were running concentrated lasix infusion with maintenance.The date the line was placed was on (b)(6) 2024.The mating device was a double lumen cv line.There was patient involvement but no patient harm was reported as a consequence of this event.

• Brand Name: 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC
• 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: 19467221
• Report Number: 9617594-2024-00732
• Device Sequence Number: 11614089
• Product Code: FMG
• UDI-Device Identifier: 00887709064362
• UDI-Public: (01)00887709064362
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: MC33687
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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: CONCENTRATED LASIX INFUSION WITH MAINTENANCE.; DOUBLE LUMEN CV LINE, MFR UNK.
• Patient Sex: Unknown