MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3 NANOCLAVE¿ STOPCOCK, CLAVE¿ CLEAR; STOPCOCK, I.V. SET

Catalog Number 011-AC301

Device Problem Material Separation (1562)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event involved a 3 nanoclave¿ stopcock, clave¿ clear where it was reported that the product is supposed to be bonded but came apart at the join whilst running high level drugs.The stopcock broke apart at the joint.There was patient involvement but no reported harm as a result of the reported event.The medication that was used with the involved device were vasoactive drugs.There was no chemotherapy involved.There was no any hole/cut/tears/deformities in the involved product.There was no patient harm since the staff noted the leaking prior to any potential disconnection or full separation.- line changed.There was no healthcare provider harm.

• Brand Name: 3 NANOCLAVE¿ STOPCOCK, CLAVE¿ CLEAR
• 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: 18515214
• MDR Text Key: 333093956
• Report Number: 9617594-2024-00034
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709123007
• UDI-Public: (01)00887709123007(17)280501(10)13624709
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-AC301
• Device Lot Number: 13624709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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: ADRENALINE, MFR UNK; CALCIUM, MFR UNK; MILRINONE, MFR UNK; NORADRENALINE, MFR UNK; POTASSIUM, MFR UNK; VASOPRESSIN, MFR UNK