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

Model Number	371603
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pack opened and found black area on side of brush.
Additional Manufacturer Narrative
Pr: (b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Additional Manufacturer Narrative
A photo was provided for evaluation.Visual examination shows foreign matter on brush portion of the product.One sample was opened and contained the sample with the contaminated brush.Three samples were unopened and examined for any foreign contaminate and none was observed.Production personnel from brush molding and e-z scrub were consulted.The foreign substance is not imbedded within the scrub brush and appears to be grease from the molding process.Grease is used for various parts of the molding process but is out of the product stream.The brush was contaminated with the production grease and inadvertently introduced in the product stream.The most probable cause of the foreign matter is likely caused from the production process and sample being reintroduced into the product stream by an unknown cause.Process specifications and in-process inspections are established to mitigate risk of foreign matter to the product; batch record was reviewed, including all attribute data, and no deviations or discrepancies were noted that would contribute or cause this issue.Ra review of risk management document shows that severity rating is minor for this defect.This is the first compliant reported for this lot.No further action required.This failure will continue to be tracked and trended.See narrative below.
Event or Problem Description
Pack opened and found black area on side of brush.Pictures attached.

• 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: anna wehrheim ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13735252
• Report Number: 1710034-2022-00121
• Device Sequence Number: 4737247
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: (01)00382903716036
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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 Expiration Date: 02/28/2026
• Device Model Number: 371603
• Device Catalogue Number: 371603
• Device Lot Number: 1056993
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/08/2022
• 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