MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" SMALLBORE EXT SET, 4 GANG 4-WAY STOPCOCKS W/BASEPLATE, 4 REMV MICROCLAVE® CLE; STOPCOCK, I.V. SET

Catalog Number MC33324

Device Problem Disconnection (1171)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

Event Description

The event involved a 8" smallbore ext set, 4 gang 4-way stopcocks w/baseplate, 4 remv microclave® clear, clamp, rotating luer, where it was reported it disconnected.A patient was receiving norepinephrine into a central venous catheter, when the patient was turned onto his right side the intravenous (iv) line disconnected from the smallbore set, 4 gang stopcock to which it was leur lock connected.The disconnection was not identified immediately and the patient became temporarily hypotensive until the line was reconnected.The reporter stated that the product seems to be prone to having the microclave clear caps come off spontaneously during patient turns and movements.There was no report of patient harm.

• Brand Name: 8" SMALLBORE EXT SET, 4 GANG 4-WAY STOPCOCKS W/BASEPLATE, 4 REMV MICROCLAVE® CLE
• 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: 15987661
• MDR Text Key: 308489120
• Report Number: 9617594-2022-00324
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709037731
• UDI-Public: (01)00887709037731(17)261001(10)5648543
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 11/22/2022

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: MC33324
• Device Lot Number: 5648543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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; NOREPINEPHRINE, UNK MFR
• Patient Sex: Male