MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5.5" (14 CM) APPX 0.57 ML, SMALLBORE BIFUSE EXT SET W/REMV CHECK VALVE, 2 CLAMPS; STOPCOCK, I.V. SET

Catalog Number	B1700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Event or Problem Description
The event involved a 5.5" (14 cm) appx 0.57 ml, smallbore bifuse ext set w/remv check valve, 2 clamps (white, red), luer lock where the customer reported that the device was leaking from the red clamp line.There was patient involvement, no adverse event and possible delay in therapy due to having to replace line/extensions.
Additional Manufacturer Narrative
Received one b33983 smallbore bifuse ex set connected to a microclave for evaluation.As received, no visual damage or abnormalities were observed.The sample was leak tested per specification and a leak between the shunt and tapered connection of the bifurcated connector was observed.The bond where the leak was observed was separated and while the solvent application appeared even, the probable cause of the incomplete insertion was attributed to insufficient solvent coverage.The complaint of leakage can be confirmed.The probable cause is due to insufficient solvent coverage during the assembly process of manufacturing.Corrected information can be found in b2 - death date null.Updated information can be found in h6 component code.D9 - date returned to mfg: 11dec2024.

• Brand Name: 5.5" (14 CM) APPX 0.57 ML, SMALLBORE BIFUSE EXT SET W/REMV CHECK VALVE, 2 CLAMPS
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21049105
• Report Number: 9617594-2024-01921
• Device Sequence Number: 19653019
• Product Code: FMG
• UDI-Device Identifier: 00887709068438
• UDI-Public: (01)00887709068438
• 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: B1700
• 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 FLUID/INFUSATE, MFR UNK.; UNSPECIFIED IV LINE, MFR UNK.
• Patient Sex: Unknown