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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 6070112
Device Problems Cap (424); Fluid Leak (1250); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2018
Event Type  Malfunction  
Event Description

When utilizing the vial-2-bag adapter (20mm), often times the liquid leaks around the spiked area. This causes a need for an additional vial of medication to be utilized. Education and re-education has been provided to areas with high levels of complaints, including a "tip sheet". This particular product requires the spike to enter the vial precisely in the middle to prevent leaking, however the surrounding cap is flexible, which allows for misalignment and leakage. Several sporadic reports exist to document the issue, however it was noted during nursing competencies that the issue is much larger than what has been documented. Nursing leadership confirms the leakage happens regularly, but that staff accept this as "normal" occurrence. All reports indicate the issue is with the 20mm/blue device.

 
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Brand NameVIAL2BAG DC
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
WEST PHARMACEUTICAL SERVICES, INC
530 herman o. west drive
exton PA 19341
MDR Report Key7560327
MDR Text Key109785932
Report Number7560327
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/27/2018,05/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2018
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date12/01/2020
Device MODEL Number6070112
Device Catalogue Number6070112
Device LOT Number9723
OTHER Device ID Number(10)9723(90)36098126(91)60701
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/27/2018
Event Location Hospital
Date Report TO Manufacturer05/27/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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