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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE PACK; CARDIOVASCULAR PROCEDURE KIT
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MEDLINE INDUSTRIES, INC. MEDLINE PACK; CARDIOVASCULAR PROCEDURE KIT Back to Search Results
Model Number DYNJ04341O
Device Problem Crack (1135)
Patient Problem Insufficient Information (4580)
Event Date 10/12/2022
Event Type  malfunction  
Event Description
In the middle of a cardiac cath procedure, the 10 ml syringe contained contrast being infused.While the physician was injecting contrast, the 10 cc syringe split.The procedure was stopped and the cracked syringe was removed (for fear air could enter the syringe and cause an air embolus).A new syringe was placed with new contrast.It is reported that this is the second time this happened.The cracked syringe was sequestered.
 
Event Description
In the middle of a cardiac cath procedure, the 10 ml syringe contained contrast being infused.While the physician was injecting contrast, the 10 cc syringe split.The procedure was stopped and the cracked syringe was removed (for fear air could enter the syringe and cause an air embolus).A new syringe was placed with new contrast.It is reported that this is the second time this happened.The cracked syringe was sequestered.
 
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Brand Name
MEDLINE PACK
Type of Device
CARDIOVASCULAR PROCEDURE KIT
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
one medline place
mundelein IL 60060
MDR Report Key16033350
MDR Text Key305990467
Report Number16033350
Device Sequence Number1
Product Code OEZ
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,Followup
Report Date 12/06/2022,10/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberDYNJ04341O
Device Catalogue NumberDYNJ04341O
Device Lot Number22GMH778
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/06/2022
Date Report to Manufacturer12/22/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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