MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B2020
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint involved a 60" (152 cm) appx 0.4ml, smallbore ext set w/clamp, luer lock device.A small collection of fluid was reported on the syringe pump below the connection from the syringe to the tubing.The pump was noted to feel wet on the bottom.Also, they noted a small collection of fluid on the floor below the iv pole.The staff assumed it was caused from a loose connection; and the tubing was changed with a new syringe.The staff tested the connection by flushing the port with saline and noted to be a crack/leak noted on the iv tubing below the clave.There was unexpected or prolonged care.The report stated that the staff went into room to change the empty dexmedetomidine syringe.The tubing was attached to a microclave and 10 ml prefilled saline syringe these items will be returned for evaluation.There was no patient harm.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Additional contact: (b)(6).
Additional Manufacturer Narrative
Investigation summary.Received one (1) used.List #unknown, microclave extension set with micron filter; lot #unknown.One (1) used.List #b2020, 60" (152 cm) appx 0.4ml, smallbore ext set w/clamp, luer lock; lot #unknown.--> one (1) used.Ref # (b)(4), 0.9% sodium chloride injection, usp single use 10 ml syringe; lot #5062449.A crack was observed on the female luer of the transfer set.The reported complaint of a crack could be confirmed.The returned extension set was observed to have a crack on the female luer.The probable cause is due to a material issue on a vendor supplied part.A device history record review could not be conducted because no lot number(s) was/were identified.Corrective and preventative actions are in process.

• Brand Name: 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK
• 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: 22719522
• Report Number: 9617594-2025-01621
• Device Sequence Number: 15855978
• Product Code: FMG
• UDI-Device Identifier: 00887709002937
• UDI-Public: 00887709002937
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: B2020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: DEXMEDITOMIDINE SYRINGE, MFR UNK.; IV POLE, MFR UNK.; UNSPECIFIED SYRINGE PUMP, MFR UNK.
• Patient Sex: Unknown