MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR (RED,; STOPCOCK, I.V. SET

Catalog Number	MC330375
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation however investigation is not yet complete.
Event or Problem Description
The event involved a 6.5" (17 cm) appx 1.1 ml, smallbore quadfuse ext set w/4 microclave® clear (red, purple, tpn rings), 0.2 micron filter, 1.2 micron filter, 4 clamps, check valve, luer lock in which the customer reported that the device leaked at location of the clave and iv tubing connection point.The mating devices were syringe, monitor, catheter, and the medication involved was total parenteral nutrition (tpn).The customer stated that the quadfuse was in use for tpn administration.Pt with bedside glucose of 16 at 0501.D10 bolus ordered by provider and given at 0533.The nurse noted at around 0540 that there was quite a bit of fluid on the linen and the fluid smelled like tpn.Upon further investigation by the customer, the quadfuse was noted to be leaking near leur lock connection site (right before microclave connection).The quadfuse was changed out and another d10 bolus given.There was no blood loss and no unprotected chemo exposure.There was no adverse operator consequences and no medical intervention required.The device was changed out/replaced with no further problems encountered.
Additional Manufacturer Narrative
The customer received two used mc330375 smallbore quadfuse ext sets for inspection.No defects or anomalies noted.Each set was leak tested per product specifications.There was leakage from the connection of the adaptor to the check valve.The adaptor was not fully inserted into the bond pocket of the check valve.There was no leakage on the other sample.The reported complaint can be confirmed.The probable cause is due to an incomplete insertion during manual assembly in manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR (RED,
• 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: 19584502
• Report Number: 9617594-2024-00796
• Device Sequence Number: 3340652
• Product Code: FMG
• UDI-Device Identifier: 00887709085671
• UDI-Public: (01)00887709085671(17)280301(10)13551095
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (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): 08/08/2024

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: MC330375
• Device Lot Number: 13551095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: CATHETER, MFR UNK; MONITOR, MFR UNK; SYRINGE,MFR UNK; TOTAL PARENTERAL NUTRITION, MFR UNK
• Patient Sex: Unknown