MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. E-Z SCRUB BRUSH

Catalog Number	371603
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that after the discontinuation of a different device (chg scrub brush), clinicians have been pouring chlorhexidine onto a dry scrub brush.The clinicians reported that when they are squirting chlorhexidine onto the dry scrub brush, it is splashing back and getting into their eyes.As reported, there was no user harm.Based on the information provided the issue appears to be associated with a use error.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that after the discontinuation of a different device (chg scrub brush), clinicians have been pouring chlorhexidine onto a dry scrub brush.The clinicians reported that when they are squirting chlorhexidine onto the dry scrub brush, it is splashing back and getting into their eyes.Recurrence of use error could result in the need for medical intervention.As reported, there was no user harm.

• Brand Name: E-Z SCRUB BRUSH
• Common Device Name: E-Z SCRUB BRUSH
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: andrew topoulos ; 75 north fairway drive; vernon hills, IL 60061 ; 8003239088
• MDR Report Key: 20157566
• Report Number: 1710034-2024-00986
• Device Sequence Number: 8396775
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: (01)00382903716036
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 371603
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown