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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
Model Number 1181200777
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 05/13/2021
Event Type  malfunction  
Event Description
Multiple syringes, from two separate lots, were found to have what appeared to be contaminants inside the unopened packaging. Some appeared to be just in the packaging, some appeared to be inside the syringe itself. Manufacturer response for 12 ml syringe luer-lock tip, monoject 12 ml syringe (per site reporter): they first directed us back to our distributor, (b)(4), the correct contacts were made and then cardinal health requested we send the affected products to them for testing.
 
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Brand NameMONOJECT
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
CARDINAL HEALTH, INC.
3651 birchwood drive
waukegan IL 60085
MDR Report Key11929629
MDR Text Key254030062
Report Number11929629
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 05/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1181200777
Device Catalogue Number1181200777
Device Lot Number21BO6663X,20M02563X,20A08563X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/25/2021
Event Location Hospital
Date Report to Manufacturer06/03/2021
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 Unkown

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