MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 21" (53 CM) APPX 5.4 ML, TRANSFER SET W/8 CLAVE¿, 4 TRI-CONNECTORS, BACK CHECK V; STOPCOCK, I.V. SET

Catalog Number B33974

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

The event involved a 21" (53 cm) appx 5.4 ml, transfer set w/8 clave¿, 4 tri-connectors, back check valve, clamp (blue), vented cap where it was reproted the 8-port manifold was infusing mycophenylate when another manifold port with used tubing for ganciclovir disconnected below needleless connector.This caused hazardous medication spill of mycophenylate ~100 ml.Spill cleaned with spill kit and surface safe per policy.They did not sequester per material services request as infusing hazardous meds, thus no sample is returning for testing.There was patient involvement and unknown human harm however no other details were provided.

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Possible lot numbers: 13833492 manufactured date 12/2023.1386766 manufactured date 01/2024.

• Brand Name: 21" (53 CM) APPX 5.4 ML, TRANSFER SET W/8 CLAVE¿, 4 TRI-CONNECTORS, BACK CHECK V
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19029821
• MDR Text Key: 339215762
• Report Number: 9617594-2024-00359
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33974
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: GANCICLOVIR; MYCOPHENYLATE, MFR UNK