MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	011-C3302
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.Additional contact information section e (b)(6).
Event or Problem Description
The event involved a 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave®, clamp, rotating luer in which the customer stated that the device cannot connect tightly and causing leakage.The device was reported to be used for normal infusion therapy on a patient in ward 5.There were no holes, cuts, cracks, tears or defects noted.There was no bleedback, no biohazard and no chemo used.The clinical staff changed the tubing and therapy was resumed.There was no adverse event/patient harm or delay in therapy reported.This is report 7 of 12.

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17242971
• Report Number: 9617594-2023-00317
• Device Sequence Number: 12487281
• Product Code: FMG
• UDI-Device Identifier: 00840619001537
• UDI-Public: (01)00840619001537(17)270601(10)6032056
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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 Model Number: 011-C3302
• Device Catalogue Number: 011-C3302
• Device Lot Number: 6032056
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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 NORMAL INFUSION THERAPY, MFR UNK
• Patient Sex: Unknown