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

Model Number	371603
Medical Device Problem Code	Unsealed Device Packaging (1444)
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
Pr (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 opened.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
No samples or photos were provided for evaluation.As a result, bd was unable to verify the reported issue or determine a definitive root cause at this time.Review of device history review did not find any attributable deficiencies that would lead to this issue.Review of risk management document shows that severity for sterile products for leaking seal is acceptable with a remote occurrence for this defect and patient infections/complications being the potential failure mode.Possible causes of this issue could be result of incorrect set up or rejected product being inadvertently introduced back into the product stream.Review of the batch record shows that production was performed as specified and all in-process quality checks met established specifications.Review of lot history show no non-conformance events issued for this lot.Root cause for this issue cannot be established at this time.Any future complaints will continue to be monitored for this lot and assessed.H3 other text : see narrative below.
Event or Problem Description
It was reported that the pack was opened.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.

• 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: 12825295
• Report Number: 1710034-2021-00960
• Device Sequence Number: 11135953
• 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: 11/17/2021
• 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