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

Device Problem Disconnection (1171)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however has not been received.

Event 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.

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,
• Type of Device: 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
• MDR Text Key: 315966184
• Report Number: 9617594-2023-00208
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619043230
• UDI-Public: (01)00840619043230(17)280201(10)13557385
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 011-MC3316
• Device Catalogue Number: 011-MC3316
• Device Lot Number: 13557385
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: B.BRAUN INFUSION SET LN 8250917SP; DOCETAXEL, UNK MFR