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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT SYRINGE, PISTON

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CARDINAL HEALTH, INC. MONOJECT SYRINGE, PISTON Back to Search Results
Catalog Number 1181200777
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Laceration(s) (1946)
Event Date 10/12/2019
Event Type  malfunction  
Event Description
Md was attempting to inject contrast when flange broke off of syringe. The sharp edge of the broken syringe pierced through mds glove and cut mds right third digit. Site was thoroughly washed with soap and water. Md received care post exposure as per protocol.
 
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Brand NameMONOJECT
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
CARDINAL HEALTH, INC.
1222 sherwood rd
norfolk NE 68701
MDR Report Key9494828
MDR Text Key172010007
Report Number9494828
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1181200777
Device Lot Number1095094
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2019
Event Location Hospital
Date Report to Manufacturer12/19/2019
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

Patient Treatment Data
Date Received: 12/19/2019 Patient Sequence Number: 1
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