MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, Y; STOPCOCK, I.V. SET

Catalog Number AM6128

Device Problem Disconnection (1171)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device becomes available, a supplemental vigilance report will be submitted at that time.

Event Description

The complaint/event occurred on an unspecified date in the pediatric intensive care unit and involved a 10" smallbore ext set w/6-port nanoclave® manifold (orange, red, blue, purple, yellow, green rings), nanoclave® (light blue ring), check valve, clamp, rotating luer.The nurse noticed that the spin collar of the manifold had moved off of the connecting microclave on item #mc33213 and slipped down the extension tubing of the manifold.When she tried to reconnect it, it would not connect.It was reported that the spin collar threading may have been stripped or damaged.It is unknown if a patient was involved in the event, however, there was no human harm reported.

• Brand Name: 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, 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: 18298453
• MDR Text Key: 330588860
• Report Number: 9617594-2023-01112
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709086968
• UDI-Public: (01)00887709086968(17)280901(10)13759237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2023

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: AM6128
• Device Lot Number: 13759237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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