MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 72" (183 CM) APPX 1.2 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	MC33782
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a 72" (183 cm) appx 1.2 ml, smallbore ext set w/microclave® clear, clamp, rotating luer where it was reported the clinician went to pull out piperacillin/tazobactam syringe out of the syringe pump and noticed that the tubing was wet and sticky.Further inspection discovered that the 'cap' part of the tubing is logged with fluid (most likely medication).The tubing was then immediately removed.There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
Received one used list #mc33782, 72" (183 cm) appx 1.2 ml, smallbore ext set w/microclave¿ clear, clamp, rotating luer; lot #unknown.No visual damages or anomalies were observed.The reported complaint of a clogged spike could be confirmed.The returned sample was tested and no flow was observed.The probable cause of the no flow malfunction is unknown.A dhr lot # review could not be conducted because no lot number was identified.Corrected information can be found in h6 medical device problem code.

• Brand Name: 72" (183 CM) APPX 1.2 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING
• 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: 22072955
• Report Number: 9617594-2025-01090
• Device Sequence Number: 9500885
• Product Code: FMG
• UDI-Device Identifier: 00887709067240
• UDI-Public: 00887709067240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: MC33782
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/18/2025
• 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: PIPERACILLIN/TAZOBACTAM SYRINGE, UNK MFR.; SYRINGE PUMP, UNK MFR.
• Patient Sex: Unknown