MAUDE Adverse Event Report: ICU MEDICAL ONCOLOGY KIT W/ SPINNING SPIROS, C-CLIP, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number CH3581

Patient Problem Chemical Exposure (2570)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

Medication leaked out between distal end of primary tubing and spiros closed system drug-transfer device (cstd).Medication was mycophenolate which is classified as a high-risk hazardous drug.Patient had exposure to medication that leaked out onto his bedding.Patient did not receive full dose of medication.

• Brand Name: ONCOLOGY KIT W/ SPINNING SPIROS, C-CLIP, RED CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 18563438
• MDR Text Key: 333487730
• Report Number: 18563438
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2023

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 Model Number: CH3581
• Device Catalogue Number: CH3581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Male
• Patient Weight: 68 KG