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U.S. Department of Health and Human Services

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

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ICU MEDICAL, INC. ICU MEDICAL SPINNING SPIROS CLOSED MALE LUER SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number CH2000S-C
Device Problems Crack (1135); Fluid 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).
 
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Brand NameICU MEDICAL SPINNING SPIROS CLOSED MALE LUER
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
MDR Report Key12925256
MDR Text Key281833810
Report NumberMW5105765
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCH2000S-C
Device Lot Number5513479 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

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