MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE, 3 CLAMPS, RO; STOPCOCK, I.V. SET

Model Number	B33098
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Investigation is not complete.
Event or Problem Description
The event involved 4" (10 cm) appx 0.40 ml, smallbore trifuse ext set w/3 microclave®, 3 clamps, rotating luer that the customer reported an unknown substance inside one of the trifuse.The device was stored in a supply room.There was patient involvement and no report of harm.
Additional Manufacturer Narrative
Received one used list #b33098, 4" (10 cm) appx 0.40 ml, smallbore trifuse ext set w/3 microclave®, 3 clamps, rotating luer; lot #5086239.As received, amber colored fluid residuals were present within the tubing of the set.Dried red residuals were also observed inside the tubing bonded within the trifurcated connector.The tubing was disassembled from the trifurcated connector and it was confirmed the residuals were lose within the fluid path.No other damage or anomalies were identified on the set.The reported complaint can be confirmed.The probable cause of the unknown residuals observed is due to the infusates administered during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE, 3 CLAMPS, RO
• 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
• MDR Report Key: 11582021
• Report Number: 9617594-2021-00102
• Device Sequence Number: 4296446
• Product Code: FMG
• UDI-Device Identifier: 00887709006263
• UDI-Public: (01)00887709006263(17)251101(10)5086239
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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 Expiration Date: 11/01/2025
• Device Model Number: B33098
• Device Catalogue Number: B33098
• Device Lot Number: 5086239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1