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	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
The event occurred on an unknown date in (b)(6) of 2024 involving 7" smallbore ext set w/1.2 micron filter, clamp, rotating luer where a report stated that an rn noted large air bubble past 1.2 micron (lipid) filter.Required detaching lipids line from patient in order to get air out.The decision was made to remove current filter and place new filter.Air did not reach patient.The event occurred in the hospital.There was patient involvement and unknown adverse events.It was unknown on how long into the infusion was the air bubble noted.The air bubble was large.It was unknown what was the length of the tubing the air bubbles were in.It was unknown how the tubing was set-up.It was unknown if the drip chamber was filled before the bubbles were noted.It was unknown if a pump was used during the infusion.It was unknown if it alarms for air in line.
Additional Manufacturer Narrative
Although the device was requested multiple times to be returned for evaluation, it has not been received.The reported complaint of an air bubble could not be confirmed.Without the return of the sample or a photo/video, a comprehensive review cannot be performed and a probable cause cannot be determined.No lot received for a dhr review.Corrected information can be found in g2.Additional contact information: (b)(6).

• 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: 20852165
• Report Number: 9617594-2024-01737
• Device Sequence Number: 8039602
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: LIPIDS, MFR UNK.
• Patient Sex: Unknown