MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® (RED, GLOW RING), 0.2 MICRON FILTE; STOPCOCK, I.V. SET

Catalog Number	B33034
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 12" smallbore trifuse ext set w/3 microclave® (red, glow ring), 0.2 micron filter, 3 clamps, rotating luer.Upon removing the medication tubing or a syringe from the red port (that the facility uses for an intravenous medication push or for connection to medication tubing for continuous infusion purposes), the inner clear valve became stuck.Although fluid leakage was not noticed at the time, fluid was eventually identified on the linen of a bed.There was no human harm associated with this complaint/event.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.The customer identified two possible lot numbers (plots): 13882127 (expiry date 01/01/2029, mfr date 02/01/2024); 13861789 (expiry date 12/01/2028, mfr date 01/01/2024).Section e additional reporting contact: (b)(6).
Additional Manufacturer Narrative
Received one used b33034 smallbore trifuse ext set w/3 microclaves for inspection.No defects or anomalies noted.Fluid was infused through each microclave and leak tested per product specifications.There was no leakage.The reported complaint of leakage could not be confirmed.Device history record reviews of the possible lot numbers and relevant commodities were reviewed.No relevant non conformities were found that would have led to the reported complaint.

• Brand Name: 12" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® (RED, GLOW RING), 0.2 MICRON FILTE
• 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: 19661531
• Report Number: 9617594-2024-00862
• Device Sequence Number: 15088089
• Product Code: FMG
• UDI-Device Identifier: 00887709005921
• UDI-Public: (01)00887709005921
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: B33034
• Device Lot Number: PLOT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED MEDICATION TUBING, MFR UNK.; UNSPECIFIED SYRINGE, MFR UNK.
• Patient Sex: Unknown