MAUDE Adverse Event Report: CAREFUSION SMARTSITE VIALSHIELD

Model Number MV0528

Device Problems Break (1069); Fail-Safe Design Failure (1222)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

During preparation of cisplatin 45 mg iv bag, while trying to remove the syringe containing the cisplatin from the carefusion device mv0528 smartsite vialshield, the needle free valve portion of the mv0528 broke off.No harm occurred to the technician preparing the dose, as no obvious spray of cisplatin occurred and the technician was appropriately gowned and double gloved.No visible leakage was noted.Filled syringe and the defective device (still attached to the drug vial) were double bagged in chemo transport bags and shipped to the manufacturer for analysis.

• Brand Name: SMARTSITE VIALSHIELD
• Type of Device: SMARTSITE VIALSHIELD
• Manufacturer (Section D): CAREFUSION; san diego 92130
• MDR Report Key: 4138181
• MDR Text Key: 4797282
• Report Number: MW5038425
• 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: 09/29/2014

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: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: MV0528
• Device Lot Number: 4210
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 97