MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13CM APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE, ROTATING LUER LOCK; STOPCOCK, I.V. SET

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/28/2024

Event Type  malfunction  

Event Description

The event involved an unspecified 13cm appx 0.33ml, smallbore bifuse ext set w/2 microclave, rotating luer lock where it was reported that the device failed during the delivery of inotropes.The status of the product at time of event was connected to a central venous catheter (cvc) with an inotrope infusion running through.The syringe and line had recently been changed but the device remained unchanged.It was reported the patient's blood pressure began to drop and there was fluid visibly leaking from the device onto the patient's pillow and sheet.Patient had a significant drop in blood pressure that required a medical intervention of a medical review.Patient was stabilized.One side of the double bio connector appeared to be leaking when flushed from around the base of the blue bung.There was patient involvement, but no patient harm noted.

Manufacturer Narrative

The device has been returned for evaluation.Investigation is pending.

Manufacturer Narrative

One used sample #unknown, bifuse extension set with two microclaves were returned for evaluation.As received no physical damage or anomalies were confirmed on the sample.No mating device was returned for evaluation.The extension set was tested as per procedure and no leaks, occlusion or anomalies after priming were confirmed.Complaint of leaks cannot be confirmed or replicated.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 13CM APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE, ROTATING LUER LOCK
• 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: 18797743
• MDR Text Key: 337583074
• Report Number: 9617594-2024-00204
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: CENTRAL VENOUS CATHETER, UNK MFR; INOTROPE, UNK MFR