MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" EXT SET W/0.2 MICRON FILTER, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B1205
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one (1) used b1205 ext set w/0.2 micron filter for inspection.As received, the tubing was separated from the inlet port of the filter.The tubing at the outlet port of the filter was tested for bond integrity for representative testing.The bond met performance expectations with the tubing remaining intact.The tubing was measured and was found to meet dimensional specifications.The reported complaint can be confirmed.The probable cause is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
Received one (1) used b1205 ext set w/0.2 micron filter for inspection.As received, the tubing was separated from the inlet port of the filter.The tubing at the outlet port of the filter was tested for bond integrity for representative testing.The bond met performance expectations with the tubing remaining intact.The tubing was measured and was found to meet dimensional specifications.The reported complaint can be confirmed.The probable cause is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that, on an unknown date, a 12" ext set w/0.2 micron filter, luer lock experienced a disconnection of the device during patient use.It was stated in the report that the tubing broke apart at the point it connected to the filter itself.This is the 3rd time this has happened.They did not save the first 2 filters.They thought maybe it was just a fluke, but with this 3rd failure, they wanted to report it.There was unknown patient involvement, unknown patient harm, and unknown delay in therapy.

• Brand Name: 12" EXT SET W/0.2 MICRON FILTER, 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: 19572029
• Report Number: 9617594-2024-00786
• Device Sequence Number: 17183712
• Product Code: FMG
• UDI-Device Identifier: 00887709000728
• UDI-Public: (01)00887709000728
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2024

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: B1205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 06/20/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 06/22/2024; 07/07/2024
• 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
• Patient Sex: Unknown