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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a 9" ext set w/0.2 micron filter, clamp, rotating luer experienced a break.The reporter stated the tube/set broke while being used with a patient.The set-up included a 250ml bag of normal saline spiked with a meter tubing, which was then attached to the filter.The medication involved was remicade.It was further reported that the tubing setup was not replaced and therapy was not resumed.The patient was informed of how much medication was left in the infusion bag.The patient only had what was left in the priming chamber.The patient was asked if she wished to continue with what was left, however, the patient denied it.No medication intervention was required, the patient was disconnected and went home.There was patient involvement and no human harm was reported, the patient just got upset for getting wet on her arm and leg.

• 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: 18107889
• Report Number: 9617594-2023-00964
• Device Sequence Number: 5698643
• Product Code: FMG
• UDI-Device Identifier: 00887709040625
• UDI-Public: (01)00887709040625(17)280701(10)13716157
• 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
• Report Date (Section B): 11/09/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NORMAL SALINE; REMICADE, UNK MFR
• Patient Sex: Unknown