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	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Used device was returned for evaluation.No damages or anomalies were noted.The set was leak tested per product specifications and a leak was observed at the bond area from the connector to shunt.The reported complaint can be confirmed; probable cause is due to a bond error during manual assembly in manufacturing.One new set was also received for evaluation; there was no leakage on the new set.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
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 which was reported to leak during patient use from the proximal connection point, right above (distal to the collar).There was patient involvement and reported delay in therapy; there was no adverse patient or operator consequences and no medical intervention required.This is report one of five.
Additional Manufacturer Narrative
Updated information from evaluation - there was a leak from the bond area between the quadfuse connector male luer of the back check valve on the used sets.The lot history was reviewed, 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: 18696547
• Report Number: 9617594-2024-00144
• Device Sequence Number: 20614891
• 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
• 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): 03/22/2024

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: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown