MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" BIFUSE EXT SET W/2 MICROCLAVE¿, 2 CLAMPS, LUER LOCK; STOPCOCK, I.V. SET

Model Number	B3369
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	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 9" bifuse ext set w/2 microclave¿, 2 clamps, luer lock.It was reported that the patient reported seeing a piece of blue plastic floating around in the line of the tubing.There was patient involvement, however no report of patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Additional Manufacturer Narrative
Received one used.List #b3369, 9" bifuse ext set w/2 microclave¿, 2 clamps, luer lock; lot #13559366 and a photo showing a blue piece of plastic inside the fluid path at the bifurcated junction of the b3369 bifuse ext set assembly.A small piece of blue plastic was confirmed to be within the fluid path of the b3369 bifuse ext set assembly.It was discovered that the blue piece of plastic would have been too large to have originated from the two microclave assemblies into the interior of the b3369 bifuse ext set assembly.There were no missing blue pieces of plastic within ether of the two microclave assemblies.The blue piece of plastic could have originated from a source that connected to the male luer at the distal end of the b3369 bifuse ext set assembly but no devices were returned for investigation that would have been connected at that end of the assembly.The probable source of the blue plastic particle was unable to be determined, but there is nothing to suggest that it originated from the returned b3369 bifuse ext set assembly.The device history review (dhr) for lot 13559366 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: 9" BIFUSE EXT SET W/2 MICROCLAVE¿, 2 CLAMPS, 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17006545
• Report Number: 9617594-2023-00209
• Device Sequence Number: 6296205
• Product Code: FMG
• UDI-Device Identifier: 00887709008458
• UDI-Public: (01)00887709008458(17)280301(10)13559366
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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 Model Number: B3369
• Device Catalogue Number: B3369
• Device Lot Number: 13559366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• Patient Sex: Unknown