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

Catalog Number	371603
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a return sample evaluation of separate customer complaint, two samples were found to be missing the lot number, expiration date, and qr/barcode on the unit package.
Additional Manufacturer Narrative
Two samples were identified to be missing the lot number, expiration date, and qr/barcode on the unit package.A review of the batch record did not identify any discrepancies or deviations of the production of the batch.A review of the packaging process identified that the two affected products would have been rejected by the vision system as they did not have a barcode.The probable root cause is human error.It is likely an operator introduced scrap product onto the conveyor belt in the good product stream and did not record the reintroduction.This conclusion is based on the automatic, continuous process and the defect is random and does not affect the other units adjacent in the process flow.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
During a return sample evaluation of separate customer complaint, two samples were found to be missing the lot number, expiration date, and qr/barcode on the unit package.
Additional Manufacturer Narrative
Two samples were identified to be missing the lot number, expiration date, and qr/barcode on the unit package.A review of the batch record did not identify any discrepancies or deviations of the production of the batch.A review of the packaging process identified that the two affected products would have been rejected by the vision system as they did not have a barcode.The probable root cause is human error.It is likely an operator introduced scrap product onto the conveyor belt in the good product stream and did not record the reintroduction.This conclusion is based on the automatic, continuous process and the defect is random and does not affect the other units adjacent in the process flow.Addendum: a capa has been opened to further investigate this issue.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.

• 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: 20571531
• Report Number: 1710034-2024-01238
• Device Sequence Number: 12905364
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: (01)00382903716036(11)240219(17)290131(10)4031325
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 4031325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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