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

Model Number	371603
Medical Device Problem Codes	Unsealed Device Packaging (1444); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No clinical signs, symptoms or conditions.No patient involvement.Unsealed device packaging.(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
Material no.371603, batch no.0182223.It was reported that package was sealed incorrectly.Verbatim: a staff member called on 23-mar-2021 from this facility to report an incident that [customer] witnessed.This e-z scrub package had 2-3 different packages that were difficult to open and seemed like the side they normally open was not sealed properly.Customer has product available for return.
Additional Manufacturer Narrative
Follow up e mdr: root cause cannot be determined from the manufacturing investigation.Inspection of the returned samples show that the product is difficult to open.No other complaints from this lot have been logged.Product is non-drug and no retain samples are available for inspection.Possible root cause for this complaint is extended dwell time of machine; however, nothing was noted in the batch record to indicated that dwell time is the cause of this complaint.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Material no.371603, batch no.0182223.It was reported that package was sealed incorrectly.Verbatim: a staff member called on (b)(6) 2021 from this facility to report an incident that [customer] witnessed.This e-z scrub package had 2-3 different packages that were difficult to open and seemed like the side they normally open was not sealed properly.Customer has product available for return.

• 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: 11683605
• Report Number: 1710034-2021-00315
• Device Sequence Number: 16897812
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: (01)00382903716036
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 06/30/2025
• Device Model Number: 371603
• Device Catalogue Number: 371603
• Device Lot Number: 0182223
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 04/18/2021
• Supplement Report FDA Received Date: 07/14/2021
• Patient Sequence Number: 1