MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 1.7ML SMALLBORE EXT SET W/CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B2032
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received a series of photos of the packaging and the affected sample.The photo of the sample circled non-icu medical products.No conclusions could be made from the photo.The reported complaint of a leak could not be confirmed from the photo provided.Without the return of the sample a comprehensive test cannot be performed and a probable cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in h6 component codes.
Event or Problem Description
The event involved a 60" (152 cm) appx 1.7ml smallbore ext set w/clamp, luer lock where it was reported that the tubing was leaking at the connection hub during albumin infusion.The patient did not receive the full albumin infusion and had to be re-dosed.They are connecting the tubing directly to the peripheral intravenous (piv) catheter.The event occurred multiple times with different patients.There was patient involvement and unknown adverse events.
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending completion.

• Brand Name: 60" (152 CM) APPX 1.7ML 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: 22332876
• Report Number: 9617594-2025-01348
• Device Sequence Number: 9160390
• Product Code: FMG
• UDI-Device Identifier: 00840619045548
• UDI-Public: (01)00840619045548(17)291101(10)14196246
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/06/2025

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: B2032
• Device Lot Number: 14196246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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: ALBUMIN, MFR UNK.; PERIPHERAL INTRAVENOUS (PIV) CATHETER, MFR UNK.
• Patient Sex: Unknown