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
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9617594-2023-00566
• Device Sequence Number: 4880549
• Product Code: FMG
• UDI-Device Identifier: 00887709012769
• UDI-Public: (01)00887709012769(17)280201(10)13551654
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown