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 Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 05/19/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

A sister device is available to be returned for evaluation; however, it has not yet been received.

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,
• 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: 14685814
• MDR Text Key: 303242665
• Report Number: 9617594-2022-00167
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619043230
• UDI-Public: (01)00840619043230(17)270101(10)5803265
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 011-MC3316
• Device Catalogue Number: 011-MC3316
• Device Lot Number: 5803265
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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: INFUSOMAT TREE, FROM B.BRAUN LN 8250917SP, LOTN 22; PACLITAXEL; UNKNOWN PHYSIOLOGICAL SERUM, UKN MFR