MAUDE Adverse Event Report: YUKON MEDICAL, LLC CAREFUSION; MV0520 20MM CLOSED VIAL ACCESS

Model Number MV0520

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

While preparing etoposide iv bag, pharmacy technician notified pharmacist that vial was leaking at attachment site of carefusion mv0520 device.Technician confirmed that device had been secured to (novaplus) etopside 500 mg/25 ml vial using the carefusion hand press, and that it had "clicked" into place.Leaking vial and carefusion mv0520 device were immediately quarantined and double bagged in chemo transport bags, and the technician immediately changed both pairs of gloves and washed her hands thoroughly.Carefusion has been notified of this product failure.

• Brand Name: CAREFUSION
• Type of Device: MV0520 20MM CLOSED VIAL ACCESS
• Manufacturer (Section D): YUKON MEDICAL, LLC; morrisville
• MDR Report Key: 4317310
• MDR Text Key: 16173104
• Report Number: MW5039430
• Device Sequence Number: 1
• Product Code: LHI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/03/2014

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 Expiration Date: 05/31/2017
• Device Model Number: MV0520
• Device Catalogue Number: SMARTSITE VIALSHIELD
• Device Lot Number: 4222
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 84