MAUDE Adverse Event Report: ICU MEDICAL, INC. 30" APPX 3.3ML, 20 DROP ADMIN SET WITH INTEGRATED CHEMO LOCK DRIP CHAMBER, SPIRO; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Lot Number 5579987

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900); Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  Injury  

Event Description

Nurse was hanging chemo (ifosfamide plus mesna), and the spike adaptor came out of the ns bag containing the chemo.The chemo spilled out of the bag onto the floor and onto the nurses chemo gown; 50 - 60 mls spilled.The spilled chemo was cleaned up per protocol using the chemo spill kit.A new bag of med was made.Nothing got onto the patient.Fda safety report id # (b)(4).

• Brand Name: 30" APPX 3.3ML, 20 DROP ADMIN SET WITH INTEGRATED CHEMO LOCK DRIP CHAMBER, SPIRO
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 12868534
• MDR Text Key: 281271552
• Report Number: MW5105534
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 5579987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: IFOSFAMIDE; MESNA
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 30 KG
• Patient Ethnicity: Hispanic
• Patient Race: White