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 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved 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, a few ml of blood leaked out from one way (anti-reflux valve not working).The problem occurred during programming (in conjunction with the positioning of the peripheral venous access).The programming entered for the infusion was sterile physiological solution.The three-way connector was replaced, and therapy resumed.There was patient involvement but no patient harm.

Manufacturer Narrative

D9 - date returned to mfg on 2/26/2024.Received on used sample list #011-h2361 connected with a used needle for evaluation.As received some chemotherapy and physiological solution was observed inside the used sample, no physical sample or anomalies were confirmed.The set was primed and a leaks coming from one of the tube from trifurcate was observed, additionally was confirmed a tear in one of the tubes.No additional damage or anomalies were observed.Complaint of leaks can be confirmed based.The probable cause is due to a tear observed in the tube, that typical happened during unintentional pulling force during use.The lot history was reviewed and no nonconformities were identified that may 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: 18801314
• MDR Text Key: 337484251
• Report Number: 9617594-2024-00212
• Device Sequence Number: 1
• Product Code: FMG
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: STERILE PHYSIOLOGICAL SOLUTION, MFR UNK