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

Catalog Number	371603
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Black specs were found inside the package.
Additional Manufacturer Narrative
Customer reported that black specs were found inside the package.No patient involvement has been reported.Initial review of the samples returned confirms event however a definitive root cause has yet to be established and the investigation is ongoing.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.
Additional Manufacturer Narrative
Customer reported that black specs were found inside the package.No patient involvement has been reported.Initial review of the samples returned confirms event however a definitive root cause has yet to be established and the investigation is ongoing.Addendum: from samples received, debris foreign matter was confirmed.A device history record review found no non-conformances associated with this issue during production of this batch.While a definitive root cause could not be established, the foreign matter is likely caused by an unknown cause in the production process.Process specifications and in-process inspections are established to mitigate the risk of foreign matter to the product.Complaints are monitored and reviewed for emerging trends.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
Black specs were found inside the package.

• 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: 20440507
• Report Number: 1710034-2024-01140
• Device Sequence Number: 8343068
• 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: 09/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/14/2024
• 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