MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1478
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received with regards to 7" (18cm) smallbore ext set w/1.2 micron filter, clamp, rotating luer that experienced leakage during use.The report stated that called to bedside due to blood backing up into picc line.On further assessment, it was noted that the tpn/il infusion was leaking from somewhere.Able to flush blood through line and clear line with tpn and lipids clamped.Further inspection showed that the line was leaking between lipids and the trifuse.Medical team opted just to replace lipid line.
Additional Manufacturer Narrative
Additional phone number: ; (b)(6) the device has been received.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Investigation summary received one (1) used b1478 smallbore ext set w/1.2 micron filter attached to one (1) used list #unknown extension set for inspection.No defects or anomalies noted.The b1478 smallbore ext set and list #unknown extension set were leak tested per product specifications.There was no leakage.The reported complaint was unable to be replicated or confirmed.A device history record lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 7" SMALLBORE EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
• 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: 21634687
• Report Number: 9617594-2025-00498
• Device Sequence Number: 7480538
• Product Code: FMG
• UDI-Device Identifier: 00887709001916
• UDI-Public: 00887709001916
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 04/28/2025

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: B1478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• 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: 04/01/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PICC LINE, MFR UNKNOWN.; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.
• Patient Sex: Unknown