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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. MICROCLAVE SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL, INC. MICROCLAVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2017
Event Type  malfunction  
Event Description
Rn disconnected patient's iv tubing to flush cvl with heparin. After flushing the line and removing the syringe from clave, rn noticed that the rubber piece in the clave did not retract back to top of hub. The rubber piece was stuck inside the clave. Thus, the rn needed to replace this clave for a new clave using aseptic technique.
 
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Brand NameMICROCLAVE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calie amanecer
san clemente CA 92673
MDR Report Key7182041
MDR Text Key96981835
Report Number7182041
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/21/2017
Event Location Hospital
Date Report to Manufacturer12/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/11/2018 Patient Sequence Number: 1
Treatment
NOT KNOWN.
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