MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	SC9045
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The incident involved a 9" ext set w/0.2 micron filter, clamp, rotating luer.The reporter stated that the customer had a tube/set that broke while using with a patient.The set-up included a 100ml bag of normal saline spiked with a meter tubing, which is then attached to filter.The medication involved was actemra.The tubing/set-up was not replaced, the leakage was noticed at the end of the treatment.The patient had fallen asleep and did not feel she was getting wet.The reporter could not tell how much of the treatment the patient had received; they sent the patient home with a sample pen of actemra to use if she noticed she did not have the normal relief after treatment.No medical intervention was required at that point.There was no harm associated with the event.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
A used sc9045 extension set was returned with tubing confirmed to be separated from the filter bond interface.The bond was inspected and found to have insufficient solvent applied at the bond interface.The probable cause of the bond separation is typical of insufficient solvent coverage during manual bond assembly in ensenada.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 9" EXT SET W/0.2 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: 18048181
• Report Number: 9617594-2023-00907
• Device Sequence Number: 18206338
• Product Code: FMG
• UDI-Device Identifier: 00887709040625
• UDI-Public: (01)00887709040625(17)280701(10)13716157
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/27/2023

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: SC9045
• Device Lot Number: 13716157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACTEMRA, MFR UNK.; NORMAL SALINE, MFR UNK.
• Patient Sex: Unknown