MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B1479
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 8" smallbore ext set w/0.2 micron filter, clamp, luer lock.It was reported that the device's filter had either occlusion issues or leaking.It was confirmed that the facility is using this product within the manufacturer recommendations.There was no human harm reported.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
The following devices were received for complaint investigation: -four used list #b1479, 8" smallbore ext set w/0.2 micron filter, clamp, luer lock; lot #9286060 -one new list #b1479, 8" smallbore ext set w/0.2 micron filter, clamp, luer lock; lot #9286060 two of the four used b1479 extension set samples experienced occluded flow during priming.One of the four used b1479 extension set samples leaked at the filter vents during testing.The other two used b1479 extension set samples primed without difficulty and did not leak during testing.The new b1479 extension set primed without difficulty and did not leak during testing.Occluded flow was confirmed in two of the returned samples.The probable cause is filter occlusion during during use.The dfu states: a filter that clogs during infusion should be replaced.Leaking from the filter vent was confirmed in one of the returned samples.The probable cause of the observed leak is temporary or permanent loss of the hydrophobic properties of the filter vent material due to infusate interaction.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
The following devices were received for complaint investigation: -four used list #b1479, 8" smallbore ext set w/0.2 micron filter, clamp, luer lock; lot #9286060 -one new list #b1479, 8" smallbore ext set w/0.2 micron filter, clamp, luer lock; lot #9286060 two of the four used b1479 extension set samples experienced occluded flow during priming.One of the four used b1479 extension set samples leaked at the filter vents during testing.The other two used b1479 extension set samples primed without difficulty and did not leak during testing.The new b1479 extension set primed without difficulty and did not leak during testing.Occluded flow was confirmed in two of the returned samples.The probable cause is filter occlusion during during use.The dfu states: a filter that clogs during infusion should be replaced.Leaking from the filter vent was confirmed in one of the returned samples.The probable cause of the observed leak is temporary or permanent loss of the hydrophobic properties of the filter vent material due to infusate interaction.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
The following devices were received for complaint investigation: -four used list #b1479, 8" smallbore ext set w/0.2 micron filter, clamp, luer lock; lot #9286060 -one new list #b1479, 8" smallbore ext set w/0.2 micron filter, clamp, luer lock; lot #9286060 two of the four used b1479 extension set samples experienced occluded flow during priming.One of the four used b1479 extension set samples leaked at the filter vents during testing.The other two used b1479 extension set samples primed without difficulty and did not leak during testing.The new b1479 extension set primed without difficulty and did not leak during testing.Occluded flow was confirmed in two of the returned samples.The probable cause is filter occlusion during during use.The dfu states: a filter that clogs during infusion should be replaced.Leaking from the filter vent was confirmed in one of the returned samples.The probable cause of the observed leak is temporary or permanent loss of the hydrophobic properties of the filter vent material due to infusate interaction.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" SMALLBORE EXT SET W/0.2 MICRON FILTER, 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: 17754884
• Report Number: 9617594-2023-00715
• Device Sequence Number: 7010873
• Product Code: FMG
• UDI-Device Identifier: 00887709001923
• UDI-Public: (01)00887709001923(17)270901(10)9286060
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/22/2023

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 Catalogue Number: B1479
• Device Lot Number: 9286060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 10/02/2023; 10/02/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/23/2023; 10/23/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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