MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 I; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126640489
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a primary set, piggyback with backcheck valve, 3 clave y-sites, secure lock, 100 inch.It was reported that fluid just keeps on running out when they spike the infusion bag.Further, there was no wheel to pinch the tubing present on the defective device.There was no report of any human harm.
Additional Manufacturer Narrative
Although multiple attempts were made to obtain the device, it is not available for investigation at this time.A review of the device history record is pending.Additional contact information: kpril robinson complaint coord i medline industries 224-931-6522 kqrobinson@medline.Com.
Additional Manufacturer Narrative
Investigation summary: no 126640489 product samples, videos or photographs were returned for investigation.The dhr was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.
Additional Manufacturer Narrative
Received one (1) opened/unused list # 126640489, primary set, piggyback with backcheck valve, 3 clave y-sites, secure lock, as received, the roller wheel is missing in the pinch clamp.No other anomalies or damage observed.Without the roller wheel, the customer complaint is confirmed, the fluid just keeps running out because there isn't a wheel to pinch the tubing.Probable cause, assembly error.The device history review for lot number 14126181 was reviewed and there were no non-conformances found that would have contributed to the reported complaint.Additional note.This complaint occurred when the clinician spiked the bags.This would occur prior to patient connection.H6 code has been updated to no patient involvement.D9 device returned for investigation on 05/27/2025.

• Brand Name: PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 I
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21883260
• Report Number: 9615050-2025-00192
• Device Sequence Number: 12947217
• Product Code: FPA
• UDI-Device Identifier: 10887787005964
• UDI-Public: (01)10887787005964(17)271001(10)14126181
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142367
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2025

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: 126640489
• Device Lot Number: 14126181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 06/25/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/29/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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: UNSPECIFIED INFUSION BAG, MFR UNK
• Patient Sex: Unknown