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 Codes	Crack (1135); Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved 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 where it was reported product cracked-line leaking.The status of the product at the time of event was during patient use.There was patient involvement, no adverse event and possible delay in therapy due to having to replace line/extensions.Information on specific fluid or medication is not available.
Additional Manufacturer Narrative
One used b33982 smallbore quadfuse ex set connected to a microclave was received for evaluation.As received, there was no visual damage or any abnormalities observed.The used device was leak tested and a leak between the shunt and tapered connection of the quadfuse connector was observed.The bond where the leak was observed was separated and insufficient solvent coverage was found.The complaint of leakage was confirmed.The probable cause is due to insufficient solvent coverage during the manufacturing assembly process.Corrected information can be found in d10 and h6: health effect - impact code.Updated information can be found in h6 medical device problem code and h6 component code.D9 - date returned to mfg: 12dec2024.

• 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: 21049103
• Report Number: 9617594-2024-01920
• Device Sequence Number: 3278986
• 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
• Report Date (Section B): 03/10/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED IV LINE, MFR UNK.
• Patient Sex: Unknown