MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS,; STOPCOCK, I.V. SET

Model Number	011-MC3316
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal luer connection of a braun device disconnected from the microclave, which was connected to the patient and administering paclitaxel and physiological serum.Due to the disconnection the drug spilled on the floor, on the patient's chair and on the patient.An infusomat tree, from b.Braun, was used with the product.The event occurred during patient use, however, there was no delay in therapy, no adverse event and no one was harmed as a result of this event.
Additional Manufacturer Narrative
A sister device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
The complaint of leakage could not be confirmed or replicated on the returned new one (1) new.List #011-mc3316, 6" (15cm) appx 0.33ml, smallbore bifuse ext set w/2 microclave¿ clear, 3 clamps, rotating luer.The returned new device and mating device were leak tested per product specification.There were no leaks or disconnections observed.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information: d9 - product received 6/30/2022.

• Brand Name: 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS,
• 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: 14685814
• Report Number: 9617594-2022-00167
• Device Sequence Number: 17321536
• Product Code: FMG
• UDI-Device Identifier: 00840619043230
• UDI-Public: (01)00840619043230(17)270101(10)5803265
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2022

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-MC3316
• Device Catalogue Number: 011-MC3316
• Device Lot Number: 5803265
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: INFUSOMAT TREE, FROM B.BRAUN LN 8250917SP, LOTN 22; PACLITAXEL; UNKNOWN PHYSIOLOGICAL SERUM, UKN MFR
• Patient Sex: Unknown