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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT BLOOD COLLECTION 21 G X 3/4; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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CARDINAL HEALTH, INC. MONOJECT BLOOD COLLECTION 21 G X 3/4; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8881225299
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 11/30/2020
Event Type  malfunction  
Event Description
I was informed that our standard 21g butterfly needles have been temporarily replaced with the "monoject blood collection 21 g x 3/4".This particular model we have noticed can come unsheathed very easily and may cause a needle stick.I pulled out a kit to do a blood draw on a patient and noticed the plastic that covered the needle pulled the sheath with and safened the needle before i could do anything with it.I brought this to the charge nurse at the time and when we examined the product we felt this would be a very easy way for someone to accidentally poke themselves.No one was hurt by this product but we felt the need to report it before someone did.Also the vacutaner attachment falls off from the needle /tubing.All product was pulled and will not be used.
 
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Brand Name
MONOJECT BLOOD COLLECTION 21 G X 3/4
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
CARDINAL HEALTH, INC.
3651 birchwood drive
waukegan IL 60085
MDR Report Key10945586
MDR Text Key219502357
Report Number10945586
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8881225299
Device Catalogue Number8881225299
Device Lot Number182640265
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2020
Event Location Hospital
Date Report to Manufacturer12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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