MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1115
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.Suspected medical device: the customer did not provide the device information.All known information is based in the investigation finding the product to be b1115.The lot#, expiration date, and manufacture date are unknown.Investigation summary received two (2) used partial tubing with filter.As received the incoming tube of one of the filters was observed to be missing.The outgoing tube of the other filter was observed to be missing.The received sets appear to be item # b1115.The complaint of detachment can be confirmed.The probable cause was due to insufficient solvent applied during manual assembly process in ensenada.
Event or Problem Description
A complaint was received with regards to a 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer that experienced separation during infusion.There was patient involvement.This is 2 of 2 reports.The report states that 2 lipid tubings was detached.The issue was tubing detached at the filter.The status of the product at the time of the event was in use and infusing lipids on a patient.When customer asked "was anyone harmed as a result of event?" she answered that "tubing was connected to a central line increasing the chances for infection.".

• Brand Name: 12" (30 CM) EXT SET W/1.2 MICRON FILTER, 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20642426
• Report Number: 9617594-2024-01585
• Device Sequence Number: 7443388
• Product Code: FMG
• UDI-Device Identifier: 00840619045524
• UDI-Public: 00840619045524
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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: B1115
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK
• Patient Sex: Unknown