MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4¿ (10CM) SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE, 3 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It was reported that a 4¿ (10cm) smallbore trifuse ext set w/3 microclave, 3 clamps, rotating luer, became disconnected.The medication involved is ara-c; it was infusing during the time of disconnection.A small drop of ara-c become in contact with the father- father rinsed off.This is the first disconnection that they have had recently with a triple.They often place a triple to provide additional access to a single lumen.There was no patient harm reporter.This is the first of nine occurrences.

Manufacturer Narrative

A disconnect between the distal male spin luer of the trifuse set and the female luer of the spinning spiros was confirmed.There was no damage or anomaly on the spinning spiros that would have been the cause of a premature disconnect.The spin feature met product performance and dimensional expectations.The male luer spin collar retention met product performance expectations.The probable cause of the disconnect cannot be determined.

• Brand Name: 4¿ (10CM) SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE, 3 CLAMPS, ROTATING LUER
• 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: 17513629
• MDR Text Key: 321331547
• Report Number: 9617594-2023-00537
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• 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: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• 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: ARA-C, UNK MFR