MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL SPINNING SPIROS CLOSED MALE LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number CH2000S-C

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

A crack in the spinning spiros ref# (b)(4) was evident in a hazardous sterile compounding preparation of an azacitidine drawn in a syringe, to be administered subcutaneously to a patient.This crack appears to be running almost the length of the spinning spiros.When pressure is applied to the syringe plunger, the hd medication sprays out through this crack.Medication was discarded as per the facility's medication waste disposal policy and a new csp was prepared for administration.Fda safety report id# (b)(4).

• Brand Name: ICU MEDICAL SPINNING SPIROS CLOSED MALE LUER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 12925256
• MDR Text Key: 281833810
• Report Number: MW5105765
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH2000S-C
• Device Lot Number: 5513479 OR 5513470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1