MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD E-Z SCRUB¿ PREOPERATIVE SURGICAL SCRUB BRUSHES; DISPOSABLE SCRUB BRUSH

Catalog Number	371603
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on 04/05/2018 via medwatch #5076355.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter described as ¿dark, smelly, mold like substance¿ was found on a bd e-z scrub¿ preoperative surgical scrub brush.The brush was not used and there was no report of injury or medical interventions.
Additional Manufacturer Narrative
One sample unit was received for evaluation by our quality engineer.Upon microscopic examination, the foreign matter present on the returned sample was identified as grease.Sample does not meet specifications.Foreign matter is grease, on the surface of a few of the tines of the molded brush.A production history review for the provided lot number showed no anomalies or quality notifications that could have contributed to observed defect.Root cause: grease is likely from the molding machine, either some residue from preventative maintenance or from a localized build up mold release or "slip agent¿.

• Brand Name: BD E-Z SCRUB¿ PREOPERATIVE SURGICAL SCRUB BRUSHES
• Common Device Name: DISPOSABLE SCRUB BRUSH
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7484621
• Report Number: 1710034-2018-00214
• Device Sequence Number: 238456
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: 00382903716036
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 371603
• Device Lot Number: 7283595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other