MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD E-Z SCRUB¿ PREOPERATIVE SURGICAL SCRUB BRUSHES; DISPOSABLE SCRUB BRUSH

Catalog Number	371603
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd e-z scrub¿ preoperative surgical scrub brushes were contaminated when opened.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Returned sample confirms the presence of foreign as indicated in the returned photos.Dhr review did not show anything related to foreign matter.During packaging excess film material is trimmed from the edge of the multivac machine and removed from the process by vacuum.This happens after the package has been sealed.The foreign is much thinner than the normal trim.From the associated dirt, it was likely to have been caught in the multivac¿s drive chain and then been pulled under the machine and released at a point before the package was sealed.This is an infrequent complaint of low severity.Note that the product is terminally sterilized and that the foreign, although unsightly, would have posed no infection risk to the end user.
Event or Problem Description
It was reported that the bd e-z scrub preoperative surgical scrub brushes were contaminated when opened.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD E-Z SCRUB¿ PREOPERATIVE SURGICAL SCRUB BRUSHES
• Common Device Name: DISPOSABLE SCRUB BRUSH
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7726332
• Report Number: 1710034-2018-00472
• Device Sequence Number: 13794335
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: 00382903716036
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 371603
• Device Lot Number: 8031831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other