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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WEST PHARMACEUTICAL SERVICES, INC. VIAL2BAG DC; SET, I.V. FLUID TRANSFER
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WEST PHARMACEUTICAL SERVICES, INC. VIAL2BAG DC; SET, I.V. FLUID TRANSFER Back to Search Results
Model Number 6070111
Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/02/2018
Event Type  malfunction  
Event Description
Vial2bag would only transfer 1/2 of the medication in the vial into the bag.Tip of device was well below the level of the drug however only 1/2 of the medication would transfer.The medication was squeezed back into the vial several times with the same result.Another vial2bag was used and worked appropriately.The patient was not negatively impacted.The device was not retained.
 
Event Description
Vial2bag would only transfer 1/2 of the medication in the vial into the bag.Tip of device was well below the level of the drug however only 1/2 of the medication would transfer.The medication was squeezed back into the vial several times with the same result.Another vial2bag was used and worked appropriately.The patient was not negatively impacted.The device was not retained.
 
Event Description
Vial2bag would only transfer 1/2 of the medication in the vial into the bag.Tip of device was well below the level of the drug however only 1/2 of the medication would transfer.The medication was squeezed back into the vial several times with the same result.Another vial2bag was used and worked appropriately.The patient was not negatively impacted.The device was not retained.
 
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Brand Name
VIAL2BAG DC
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
WEST PHARMACEUTICAL SERVICES, INC.
530 herman o. west drive
exton PA 19341
MDR Report Key7629437
MDR Text Key112031280
Report Number7629437
Device Sequence Number1
Product Code LHI
UDI-Device Identifier07290108240054
UDI-Public(01)07290108240054
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6070111
Device Catalogue Number6070111
Device Lot Number9711
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2018
Event Location Hospital
Date Report to Manufacturer06/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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