MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/1.2 MICRON FILTER, CLAVE¿, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number B9041

Device Problem Disconnection (1171)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The incident involved a 14" ext set w/1.2 micron filter, clave¿, clamp, rotating luer on an unknown date.It was reported the customer had a total parenteral nutrition (tpn) extension set become disconnected while in use on a patient.There was patient involvement and unknown patient harm reported.This is the second of four reports.

Manufacturer Narrative

A couple of photos were shared by customer, where is observed basically a separation of the male-adaptor from the device, even though some of the photos were blurred the condition of separation is still clear.Complaint of disconnection / loose connection can be confirmed.The probable cause was due to insufficient solvent applied during manual process assembly in ensenada.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 14" EXT SET W/1.2 MICRON FILTER, CLAVE¿, CLAMP, 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: 17585306
• MDR Text Key: 321550872
• Report Number: 9617594-2023-00566
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709012769
• UDI-Public: (01)00887709012769(17)280201(10)13551654
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B9041
• Device Lot Number: 13551654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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