MAUDE Adverse Event Report: BD SANDY BD E-Z SCRUB

Model Number	371603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Imdrf annex e code health effect ¿ clinical code: e1714.Imdrf annex a code medical device problem code: a24.
Event or Problem Description
It was reported by the customer that one of nurse's colleagues developed a rash on arms and they are not sure if it came from the scrubbrush or the gown he was wearing.Verbatim: question: nurse wanting to know if there are any accelerants in the ez scrub brush (ref 371603, lot# 3214288).States one of her colleagues developed a rash on his arms and they are not sure if it came from the scrub brush or the gown he was wearing.Response: explained 371603 does not contain any surgical scrub solutions or accelerants.Informed the sponge ismade of polyurethane, the holder is made of polypropylene, and the bristles of the brush are polyethelyne.The nail pick is made of high density polyethtlene.
Additional Manufacturer Narrative
No samples or photos were available for evaluation.As a result, bd was unable to verify the reported issue or determine a definitive root cause at this time.The suspected product does not contain any surgical scrub solutions or accelerants.The sponge, holder, brush bristles and the nail pick are all made of polyurethane.These ingredients do not have an adherent correlation to any allergic reactions bd has investigated in the past.No further actions are required.This failure mode will continue to be tracked and trended.
Event or Problem Description
It was reported by the customer that one of nurse's colleagues developed a rash on arms and they are not sure if it came from the scrubbrush or the gown he was wearing.Verbatim: question nurse wanting to know if there are any accelerants in the ez scrub brush (ref (b)(4), lot# 3214288).States one of her colleagues developed a rash on his arms and they are not sure if it came from the scrubbrush or the gown he was wearing.Response explained 371603 does not contain any surgical scrub solutions or accelerants.Informed the sponge is made of polyurethane, the holder is made of polypropylene, and the bristles of the brush are polyethylene.The nail pick is made of high density polyethylene.

• Brand Name: BD E-Z SCRUB
• Common Device Name: BD E-Z SCRUB
• Manufacturer (Section D): BD SANDY; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BD SANDY; 9450 south state street; sandy UT 84070
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 16870484
• Report Number: 1710034-2023-00466
• Device Sequence Number: 5796501
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: (01)00382903716036
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 371603
• Device Catalogue Number: 371603
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown