MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) KIT AFFIRM ATT SYSTEM; SYSTEM, BLOOD CULTURING

Model Number	446255
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported when opening a kit affirm att system the ampule broke exposing the patient to the contents.The patient spat it out and rinsed their mouth with water.There is no report of further issue."customer problem: atts vial contents accidentally got in the patient's month the liquid got in patient's mouth, she spat it out immediately, and rinsed her mouth with water.Customer does not have any injuries and feels fine.".

• Brand Name: KIT AFFIRM ATT SYSTEM
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11327874
• Report Number: 1119779-2021-00303
• Device Sequence Number: 858435
• Product Code: LIO
• UDI-Device Identifier: 30382904462551
• UDI-Public: 30382904462551
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K920536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

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: Lay User/Patient
• Device Model Number: 446255
• Device Catalogue Number: 446255
• Device Lot Number: B01C0146M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/15/2021
• 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: Required Intervention