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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRUMMOND SCIENTIFIC COMPANY AQUA-CAP; TUBE, COLLECTION, CAPILLARY BLOOD
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DRUMMOND SCIENTIFIC COMPANY AQUA-CAP; TUBE, COLLECTION, CAPILLARY BLOOD Back to Search Results
Catalog Number 7-000-0650-LHC
Device Problem Complete Blockage (1094)
Patient Problem Insufficient Information (4580)
Event Date 06/23/2021
Event Type  malfunction  
Event Description
A blood glucose was drawn via heel stick following protocol to use drummond scientific company 65ul aqua-cap capillary (micropipettes) glucose tubes.The blood was drawn into the 65ul aqua-cap capillary tube.When the black plunger was placed in the tube immediately after drawing, the blood was clotted inside the tube and would not be drawn up by the statstrip glucose connectivity meter on the nova monitor.The process was repeated with a second capillary glucose tube, and again, it clotted.The statstrip glucose connectivity meter was then used directly on the drop of blood from the infant's heel.
 
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Brand Name
AQUA-CAP
Type of Device
TUBE, COLLECTION, CAPILLARY BLOOD
Manufacturer (Section D)
DRUMMOND SCIENTIFIC COMPANY
500 pkwy.
broomall PA 19008
MDR Report Key12226749
MDR Text Key263513234
Report Number12226749
Device Sequence Number1
Product Code GIO
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 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7-000-0650-LHC
Device Lot Number0211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/20/2021
Event Location Hospital
Date Report to Manufacturer07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age7 DA
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