MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST; DNA PROBE, YEAST

Model Number	446252
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
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.
Event or Problem Description
It was reported that bd affirm¿ vpiii microbial identification test reagent was injected into finger.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes.Did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes.Customer states the employee inadvertently injected a tiny amount of affirm vpiii reagent into her finger.
Additional Manufacturer Narrative
H.6 investigation summary: previous investigation did not reveal any changes to materials that could directly cause this injury.A review of past complaints does not indicate trend by atts batch.Bd implemented the packaging of the atts ampule crushing tool in order to prevent future occurrence of this issue.All current atts kits contain 1 tool which will be provided in each kit indefinitely.Per package insert instructions, bd strongly recommends use of this tool to eliminate chance of future injury.Bd apologizes for any issues this incident has caused.We will continue to closely monitor for trends associated with atts glass injury.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.H3 other text : see h.10.
Event or Problem Description
It was reported that bd affirm¿ vpiii microbial identification test reagent was injected into finger.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes.Did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes.Customer states the employee inadvertently injected a tiny amount of affirm vpiii reagent into her finger.

• Brand Name: BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST
• Common Device Name: DNA PROBE, YEAST
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15972584
• Report Number: 2647876-2022-00231
• Device Sequence Number: 5723890
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: 00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K931374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: Other
• Device Model Number: 446252
• Device Catalogue Number: 446252
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown