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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

Event 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 five of five.

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.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

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,
• Type of Device: 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: 18697289
• MDR Text Key: 335833119
• Report Number: 9617594-2024-00148
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1