MAUDE Adverse Event Report: INTAS PHARMACEUTICALS ETOPOSIDE VIAL 100 MG/5 ML; ETOPOSIDE VIAL 100 MG/5ML

Lot Number R07654

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/23/2015

Event Type  No Answer Provided  

Event Description

Admixing chemotherapy with secondary containment device.Rubber stopper on chemotherapy agent gave out.Lquid chemotherapy agent "sprayed" in containment (chemo hood).Technique visualized when attempt made with second vial and secondary containment device with same lot numbers and expiration dates.Technique of chemotherapy certified pharmacy technician was appropriate.Diagnosis or reason for use: secondary containment device.

• Brand Name: ETOPOSIDE VIAL 100 MG/5 ML
• Type of Device: ETOPOSIDE VIAL 100 MG/5ML
• Manufacturer (Section D): INTAS PHARMACEUTICALS
• MDR Report Key: 4737435
• MDR Text Key: 5769193
• Report Number: MW5042343
• 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: 04/23/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Lot Number: R07654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 74