MAUDE Adverse Event Report: WEST PHARMACEUTICAL SERVICES, INC VIAL2BAG DC; SET, I.V. FLUID TRANSFER

Model Number 6070112

Device Problems Fluid/Blood 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.

• 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 Key: 7560327
• MDR Text Key: 109785932
• Report Number: 7560327
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2018,05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/01/2020
• Device Model Number: 6070112
• Device Catalogue Number: 6070112
• Device Lot Number: 9723
• Other Device ID Number: (10)9723(90)36098126(91)60701
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 67