MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1016
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An event involving a 8" (20 cm) ext set w/1.2 micron filter, clamp, rotating luer experienced disconnection during patient use.The customer went in to see the patient and the patient's tubing was disconnected from the micron filter for her tpn.The filter was full of blood return and the tube was not connected to the filter anymore.¿ additional event information obtained from ufmw: the patient was a white, female.The report was completed by(b)(6), a health professional from umass (b)(6) medical center.It was mentioned under the section adverse event or product problem that it was a product problem.Update: the b1016 ext set was initially placed/used on (b)(6) 2024.There was no any issues noted or observed during flushing.One infusion infusing for 16 hours before the issue.The area where the tubing/filter separation was observed was unknown, report states the filter was no longer connected to the tubing.There was no any additional clinical observations or comments.Sample photo is not available.The device is not available to be returned for analysis/investigation as the devices were thrown away.There were no serious injuries in the reported product issue.
Additional Manufacturer Narrative
Medwatch mandatory report uf/ importer # (b)(4).
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of tubing separation could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" (20 CM) 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: 19951647
• Report Number: 9617594-2024-01112
• Device Sequence Number: 15667661
• Product Code: FMG
• UDI-Device Identifier: 00887709000087
• UDI-Public: (01)00887709000087(17)290101(10)13867908
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 09/05/2024

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: B1016
• Device Lot Number: 13867908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• 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: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.
• Patient Sex: Unknown