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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 CHECKMATE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET
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QUEST MEDICAL, INC. Q2 CHECKMATE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 9545
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation.A dhr review could not be completed as the lot number was not provided.The root cause of the reported complaint condition is unknown.Quest will continue to monitor complaint trends.
 
Event Description
A report was received regarding an alleged issue encountered during use of the intravenous administration extension set.The report states that the manifold leaked during surgery resulting in a delay in procedure.No picture of the product is available and the device is not available for return.
 
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Brand Name
Q2 CHECKMATE EXTENSION SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
QUEST MEDICAL, INC.
one allentown parkway
allen TX 75002
Manufacturer (Section G)
QUEST MEDICAL, INC
one allentown parkway
allen TX 75002
Manufacturer Contact
tosan onosode
one allentown parkway
allen, TX 75002
9723326338
MDR Report Key8376214
MDR Text Key137861181
Report Number1649914-2019-00009
Device Sequence Number1
Product Code FPK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number9545
Device Catalogue Number9545
Was Device Available for Evaluation? No
Date Manufacturer Received02/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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