MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 4.6 ML, EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LU; STOPCOCK, I.V. SET

Model Number B9061

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

Patient Problems Chemical Exposure (2570); Skin Burning Sensation (4540)

Event Date 06/04/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.However sample photos were provided, pending investigation.

Event Description

This involved a 14" (36 cm) appx 4.6 ml, ext set w/clave®, 0.2 micron filter, clamp, rotating luer where it was reported that there was a disconnection.The chemotherapy involved is continuous ara-c for 5 days.A family member was exposed to some chemotherapy on her foot.They initially reported some burning; they washed area with soap and water, no further complaints reported.The healthcare provider was wearing personal protective equipment (ppe).Chemo spill was minimal, nurse was at the bedside.There was patient involvement, however no report of patient harm.This captures one of two reports.

Manufacturer Narrative

A series of photos were shared by the customer where it was observed 2 male luers, one burette and one unknown iv set.In one of the photos there is observed one spiro not connected with the microclave, however all the configurations looks like a normal set-up for use.No additional damage or abnormally were observed.Complaint of disconnection / loose connection cannot be confirmed based in the photos shared by customer where is observed a normal set-up for use.The device history review (dhr) for lot 13552536 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 14" (36 CM) APPX 4.6 ML, EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LU
• 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: 17278326
• MDR Text Key: 318826910
• Report Number: 9617594-2023-00330
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B9061
• Device Catalogue Number: B9061
• Device Lot Number: 13552536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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: ARA-C, UNK MFR; BURETROL SET, BD ALARIS SMALLBORE TUBING 2441-0007; CH2000S WITH C-CLIP, ICU MEDICAL