MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 38 CM (15") SMALLBORE EXT SET W/3 MICROCLAVE® CLEAR, RINGS (GLOW, RED), ROTATING; STOPCOCK, I.V. SET

Catalog Number 011-MC330211

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/06/2022

Event Type  malfunction  

Event Description

It was reported that a 38 cm (15") smallbore ext set w/3 microclave® clear, rings (glow, red), rotating luer experienced a leak in the proximal tubing.The reporter stated that the sheet was stained by the norardenaline and cordarone infusion, then the leak accentuated, with the apparition of a white liquid from the proximal line (nutrition and propofol).The leaks accelerated, with the hypotension of the patient at 10.The same was noticed by the intern on call and the caregiver.The proximal tubing was replaced.No consequences for the patient besides hypotension.No additional information is available at this time.

Manufacturer Narrative

The device is expected to be returned to the manufacturer for further evaluation; however, it has not yet been received.

Manufacturer Narrative

One (1) used 38 cm (15") smallbore ext set w/3 microclave® clear, rings (glow, red), rotating luer; one (1) used unknown, extension tubing, and one (1) used bd plastipak 60 ml syringe was received and visually inspected.As received, the seal of the glow ring y-clave was torn and stuck down.Drug residuals were also present within the y-clave housing.Crazing and axial cracks were also observed on the female luer.The probable cause of the cracks is due to environmental stress applied during use.The male luer of the unknown extension set was measured and found to have an internal diameter that is incompatible with the microclave.The reported complaint can be confirmed.The probable cause of the y-clave seal damage and subsequent leakage is due to access with an incompatible mating device during use.The dfu states: the microclave connector is compatible with luers with an internal diameter (id) between 0.062" and 0.110".A device history review (dhr) could not be conducted because no lot number(s) was/were identified.

Manufacturer Narrative

Additional information: a1, a2, a3, a4, b5.

Event Description

Additional information, from the reporter, was received on may 4th, 2022 stating there was a delay in therapy for the time it took to change the devices - between 10 and 15 minutes between the observation of the issue and the change.There was medical monitoring of the hypotension during device change and blood pressure stabilization.There was no chemotherapy spill.

• Brand Name: 38 CM (15") SMALLBORE EXT SET W/3 MICROCLAVE® CLEAR, RINGS (GLOW, RED), ROTATING
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14277779
• MDR Text Key: 299583722
• Report Number: 9617594-2022-00107
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2022

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-MC330211
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 04/15/2022; 06/23/2022
• Supplement Dates FDA Received: 05/09/2022; 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CORDARONE, UKN MFR; NORARDENALINE, UKN MFR; NUTRITION, UKN MFR; PROPOFOL, UKN MFR
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 89 KG