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

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	08/26/2021
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 the pack was noted to have black debris on the sponge.Verbatim: describe the event or problem: bd e-z scrub 160 surgical scrub brush/sponge with nail cleaner pack was opened and noted to have black debris on the sponge.
Event or Problem Description
It was reported that the pack was noted to have black debris on the sponge.Verbatim: describe the event or problem: bd e-z scrub 160 surgical scrub brush/sponge with nail cleaner pack was opened and noted to have black debris on the sponge.
Additional Manufacturer Narrative
Sample or photo not submitted for review.Batch record review shows that all attributed data passed quality checks throughout the production of the lot, 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.Similar complaint (b)(4) identified the foreign matter to likely be part of the foam sponge that was burnt and not a foreign object to the sponge.Due to low complaint history for this lot, data from in-process quality checks during production, and quality control laboratory data, no further action is recommended at this time.Complaints will continue to be trended and evaluated for further action, if needed.No further actions required.

• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12775290
• Report Number: 1710034-2021-00961
• Device Sequence Number: 19759914
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: (01)00382903716036
• Combination Product (Y/N): Y
• 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: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/28/2021
• 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