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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 1186000777
Device Problems Contamination (1120); Product Quality Problem (1506)
Patient Problem Insufficient Information (4580)
Event Date 12/16/2021
Event Type  No Answer Provided  
Event Description
One of our iv room technicians found this iv syringe with brown dots on its last night when compounding in the iv room. I do not have the wrapper for the syringe so no information about lot number/expiration date. It is a 60ml, monoject syringe. The pharmacist who was in communication with me noted that it looks like a stain. She tried to scratch it off, she said it¿s not liquid/sticky. She also noted it¿s not any type of substance, more of a stain.
 
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Brand NameMONOJECT
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
CARDINAL HEALTH, INC.
15 hampshire street
building 5
mansfield MA 02048
MDR Report Key13203635
MDR Text Key283483571
Report Number13203635
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
Type of Report Initial
Report Date 12/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number1186000777
Device Catalogue Number1186000777
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/2021
Event Location Hospital
Date Report to Manufacturer01/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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