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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIAL-MATE RECONSTITUTION DEVICE; SET, I.V. FLUID TRANSFER
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VIAL-MATE RECONSTITUTION DEVICE; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number 2B8071
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a vial-mate adapter was used which resulted in a vial stopper coring issue.This was observed during preparation of intravenous medication.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Upon further investigation, it was determined that this report is a duplicate of manufacturers report # 1416980-2021-06094.All investigation activities will be captured under mfg.Report # 1416980-2021-06094.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
VIAL-MATE RECONSTITUTION DEVICE
Type of Device
SET, I.V. FLUID TRANSFER
MDR Report Key12583353
MDR Text Key274955456
Report Number1416980-2021-06105
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412027388
UDI-Public(01)00085412027388
Combination Product (y/n)Y
PMA/PMN Number
K142600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2B8071
Device Lot NumberGR21A20017
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/14/2021
Initial Date FDA Received10/06/2021
Supplement Dates Manufacturer Received10/13/2021
Supplement Dates FDA Received11/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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