PHASEAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-26 for PHASEAL manufactured by Bd.

Event Text Entries

[74042222] Our hospital just starting using phaseal closed system for our chemotherapy pt. The rationale for the device is that it is a closed system and prevents exposure of hazardous drugs a health care worker comes in contact. This is a requirement for usb 800 compliance. We sent a pt home with a 24 hour chemo pump that was hooked up with all the necessary phaseal connections and the connections where taped as well. It appears as the y connector on the drug bag was leaking chemo. The phaseal rep was onsite to see and inspect the integrity of the system. The only reason she could come up with was the connector was accessed >10 times for it to be compromised. She is doing a further investigation with the pharmacy and her company.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5069393
MDR Report Key	6529551
Date Received	2017-04-26
Date of Report	2017-04-25
Date of Event	2017-04-25
Date Added to Maude	2017-04-28
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	0

Device Sequence Number: 1

Brand Name	PHASEAL
Generic Name	PHASEAL
Product Code	ONB
Date Received	2017-04-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	1
Device Event Key	0
Manufacturer	BD

Device Sequence Number: 2

Brand Name	Y - CONNECTOR
Generic Name	Y - CONNECTOR
Product Code	GCD
Date Received	2017-04-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	2
Device Event Key	0
Manufacturer	BARD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-04-26