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 Code	Disconnection (1171)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation, however has not been received.
Event or Problem Description
The event involved a 16" (15cm) appx 0.33ml, smallbore bifuse ext set w/2 microclave¿ clear, 3 clamps, rotating luer.It was reported that a disconnection had occurred between the bioconnector and the braun tree, while docetaxel was being administered, generating a cytotoxic spill on the patient's skin.The event occur during patient use, there was a delay in therapy, however no one was harmed as a result of this event.
Additional Manufacturer Narrative
Device received on 6/22/2023 for evaluation.One new and one used sample list #011-mc3316, one used b.Braun infusion set, one cloruro sodico 0,9% baxter viaflo 50 ml intravenous bag, one cloruro sodico 0,9% baxter 250 ml intravenous bag with docetaxel, one cloruro sodico 0,9% fresenius kabi freeflex 50 ml intravenous bag and one used perfusion intravenosa 50 ml bottle were returned for evaluation.As received no damage or abnormally were observed in icu medical product.Both sets were leaked tested according procedure and no leaks were observed along the device, male luer were found within specification.Complaint of leaks cannot be confirmed based in the physical sample evaluation (used and new sample).

• 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: 17005537
• Report Number: 9617594-2023-00208
• Device Sequence Number: 6343610
• Product Code: FMG
• UDI-Device Identifier: 00840619043230
• UDI-Public: (01)00840619043230(17)280201(10)13557385
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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-MC3316
• Device Catalogue Number: 011-MC3316
• Device Lot Number: 13557385
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: B.BRAUN INFUSION SET LN 8250917SP; DOCETAXEL, UNK MFR
• Patient Sex: Unknown