MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10 CM (4") PUR SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 RINGS (RED, GREEN, Y; STOPCOCK, I.V. SET

Catalog Number 011-H2361

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

The event occurred on an unknown date involving a 10 cm (4") pur smallbore trifuse ext set w/3 microclave®, 3 rings (red, green, yellow), 3 clamps, rot.Ll where the customer reported that after positioning the venous access and connecting the three-way connector, blood leaked out from one way (anti-reflux valve not working).There was unknown patient involvement and unknown patient harm.

Manufacturer Narrative

The device is available for evaluation- it has not been received.

Manufacturer Narrative

No product samples were returned for investigation, however, a series of photographs were returned showing a the outside of a 011-h2361 unit package and another showing one of the microclaves at the proximal end of a trifuse extension set with the silicone seal stuck down.No other anomalies or damage were observed from the photo.Without return of the affected sample a comprehensive investigation cannot be conducted and a probable cause cannot be determined.The device history report (dhr) for lot 13542768 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: 10 CM (4") PUR SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 RINGS (RED, GREEN, Y
• 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: 18340899
• MDR Text Key: 330976486
• Report Number: 9617594-2023-01164
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619017712
• UDI-Public: (01)00840619017712(17)280201(10)13542768
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 011-H2361
• Device Lot Number: 13542768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1