MAUDE Adverse Event Report: BECTON DICKINSON + COMPANY LTD. BD PHASEAL PROTECTOR (P50)

Lot Number 1410033

Device Problem Device Disinfection Or Sterilization Issue (2909)

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

Event Date 04/22/2015

Event Type  malfunction  

Event Description

I went to make chemotherapy using phaseal, noticed hair in what is supposed to be a sterile closed system transfer device.

• Brand Name: BD PHASEAL PROTECTOR (P50)
• Type of Device: PHASEAL
• Manufacturer (Section D): BECTON DICKINSON + COMPANY LTD.; dublin ; EI
• MDR Report Key: 4739461
• MDR Text Key: 5703150
• Report Number: MW5042371
• 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: 04/24/2015

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: Health Professional
• Device Expiration Date: 09/01/2019
• Device Lot Number: 1410033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1