MAUDE Adverse Event Report: BD SANDY BD E-Z SCRUB; IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX)

Model Number	371603
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported that sponge brush scrub appears to have mold on the brush.¿ verbatim: we had the following issue- do we need to pull this lot? we still have the item."when it was opened in a case and it appears to have mold on the scrub brush.Lot number 0328903" customer notified me by email on 8/27 of this issue.And in the e-mail said they still have the product item.Customer is also asking what should they do with the following scrub brushes with the same lot#! i believe this event occurred on 8/27 as this is when i was notified.
Event or Problem Description
It was reported that sponge brush scrub appears to have mold on the brush.  verbatim: we had the following issue- do we need to pull this lot? we still have the item."when it was opened in a case and it appears to have mold on the scrub brush.Lot number 0328903" customer notified me by email on (b)(6) 2021 of this issue.And in the e-mail said they still have the product item.Customer is also asking what should they do with the following scrub brushes with the same lot#! i believe this event occurred on (b)(6) 2021 as this is when i was notified.
Additional Manufacturer Narrative
Cause of the foreign matter is likely a defective section of the foam sponge (burnt sponge) per the ftir analysis performed.Batch record was reviewed, including all attribute data, and no deviations or discrepancies were noted that would contribute or cause this issue.Review of risk management document shows that severity rating is minor for this defect.This is the first compliant reported for this lot.Complaints will continue to be trended and evaluated for further action, if needed.No capa required.H3 other text : see narrative below.

• Brand Name: BD E-Z SCRUB
• Common Device Name: IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX)
• Manufacturer (Section D): BD SANDY; 9450 south state street; sandy UT 84070
• MDR Report Key: 12506374
• Report Number: 1710034-2021-00831
• Device Sequence Number: 12048644
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: (01)00382903716036
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 11/30/2025
• Device Model Number: 371603
• Device Catalogue Number: 371603
• Device Lot Number: 0328903
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other