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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA, INC. PLUM LIFESHIELD LATEX-FREE MICRODRIP SOLUSET 150 ML BURETTE PLUMSET BASIC INTRAVENOUS ADMINISTRATION SET

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HOSPIRA, INC. PLUM LIFESHIELD LATEX-FREE MICRODRIP SOLUSET 150 ML BURETTE PLUMSET BASIC INTRAVENOUS ADMINISTRATION SET Back to Search Results
Model Number 1194902
Device Problem Crack (1135)
Patient Problems Eye Injury (1845); Chemical Exposure (2570)
Event Date 03/14/2019
Event Type  malfunction  
Event Description
As clinician was putting more iv amiodarone in the iv soluset, the clinician squeezed the soluset reservoir to draw in medication. As the clinician squeezed the reservoir it cracked and discharged the amiodarone into the clinician eye. The clinician flushed the eye and reported to employee health for additional treatment. The iv soluset was retrieved and sent to biomedical for reporting. Biomedical noted cracking and splitting at the reservoir wall of the 150ml reservoir.
 
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Brand NamePLUM LIFESHIELD LATEX-FREE MICRODRIP SOLUSET 150 ML BURETTE PLUMSET
Type of DeviceBASIC INTRAVENOUS ADMINISTRATION SET
Manufacturer (Section D)
HOSPIRA, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key8439190
MDR Text Key139418123
Report Number8439190
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1194902
Device Catalogue Number1194902
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/19/2019
Event Location Hospital
Date Report to Manufacturer03/21/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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