MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES,; STOPCOCK, I.V. SET

Catalog Number	B33982
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note this report is for the malfunction of sample 1.A subsequent mdr will be filed for sample 2.Investigation summary: two (2) photos were provided by the customer, unable to confirm complaint from the photos provided.Receive done (1) used list# b33982, 5.5" (14 cm) appx 1.2 ml, smallbore quadfuse ext set w/3 clave¿, 3 check valves, 4 clamps (red, white, green, yellow), luer lock, one (1) used list# unknown, 2-way extension set with catheter.One (1) used list# b33982, 5.5" (14 cm) appx 1.2 ml, smallbore quadfuse ext set w/3 clave¿, 3 check valves, 4 clamps (red, white, green, yellow), luer lock.As received, one of the claves on sample #1 was stuck down, no other anomalies observed both samples were leak tested, confirmed leaking on both samples, after disassembly, one returned sample (sample#2) showed signs of insufficient solvent, sample #1 was retuned with one clave stuck down, after disassembly, the spike showed signs of being mated with an incompatible mating device.Complaint of leaking is confirmed, probable cause of leaking for sample #1 is due to incompatible mating device.Probable cause of leaking for sample#2 is due to insufficient solvent during assembly.
Event or Problem Description
A complaint was received regarding a 5.5" (14 cm) appx 1.2 ml, smallbore quadfuse ext set w/3 clave¿, 3 check valves, 4 clamps (red, white, green, yellow), luer lock that experienced leakage.This is 1 of 2 reports.The report stated that the device is leaking.Sample photos are provided.There was unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
Additional information in b5.
Event or Problem Description
Received additional information: the reporter stated that they have defective products that are still on hand.There was unknown delay in therapy reported.The total affected product was 1 case.
Additional Manufacturer Narrative
Note this report is for the malfunction of sample 1.Additional information in section d4.

• Brand Name: 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES,
• 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: 21635435
• Report Number: 9617594-2025-00499
• Device Sequence Number: 7480555
• Product Code: FMG
• UDI-Device Identifier: 00887709127159
• UDI-Public: 00887709127159
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 07/28/2025

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: B33982
• Device Lot Number: 14137231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/29/2025; 06/27/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/25/2025; 07/28/2025
• 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
• Patient Sex: Unknown