E-Z SCRUB 408 374081

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-10 for E-Z SCRUB 408 374081 manufactured by Becton Dickinson And Company.

Event Text Entries

[4260819] Nursing from the or is complaining that the bd e-z scrub 408 ultradex scrub brush is not as good as it was before it went on manufacturer back-order in december. The or charge nurse stated, "the brush is not sturdy enough, the sponge is not thick enough and there is not enough soap in the sponge. We have to supplement the soap from our dispensers. These complaints are from surgeons, techs and nurses. "we have two lot #'s on our shelf. We asked the or to see if there is a difference between the two lot numbers. We were told there is no difference. All pieces of each lot are affected. We moved to a different brand of surgical scrub brush to satisfy the concerns of the or.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3676515
• MDR Report Key: 3676515
• Date Received: 2014-03-10
• Date of Report: 2014-03-10
• Date of Event: 2014-02-06
• Report Date: 2014-03-10
• Date Reported to FDA: 2014-03-10
• Date Reported to Mfgr: 2014-03-13
• Date Added to Maude: 2014-03-13
• Event Key: 0
• Report Source Code: User Facility 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: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: E-Z SCRUB
• Generic Name: BRUSH, SCRUB, OPERATING-ROOM
• Product Code: GEC
• Date Received: 2014-03-10
• Model Number: 408
• Catalog Number: 374081
• Lot Number: 3351777
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON DICKINSON AND COMPANY
• Manufacturer Address: ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417

Device Sequence Number: 2

• Brand Name: E-Z SCRUB
• Generic Name: BRUSH, SCRUB, OPERATING-ROOM
• Product Code: GEC
• Date Received: 2014-03-10
• Model Number: 408
• Catalog Number: 374081
• Lot Number: 3351777 & 3340644
• ID Number: *
• Device Availability: Y
• Device Age: 1 DAY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: BECTON DICKINSON AND COMPANY
• Manufacturer Address: ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-03-10