MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD FOX¿ EXTRACTION TUBES; DNA REAGENTS, NEISSERIA

Model Number	441129
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
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 fox¿ extraction tubes contamination occurred.The following information was provided by the initial reporter: after consecutive rounds of decontamination, customer found contamination on product during an environmental run after consecutive rounds of decontamination of the lab, customer swabbed the inside of stated reagent box after using fresh ppe and before the reagent boxes were put into the lab.Customer is not ruling out that the boxes of reagents were contaminated before delivery.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2022-01463 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that bd fox¿ extraction tubes contamination occurred.The following information was provided by the initial reporter: after consecutive rounds of decontamination, customer found contamination on product during an environmental run after consecutive rounds of decontamination of the lab, customer swabbed the inside of stated reagent box after using fresh ppe and before the reagent boxes were put into the lab.Customer is not ruling out that the boxes of reagents were contaminated before delivery.

• Brand Name: BD FOX¿ EXTRACTION TUBES
• Common Device Name: DNA REAGENTS, NEISSERIA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• 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: 15925291
• Report Number: 1119779-2022-01463
• Device Sequence Number: 5077094
• Product Code: LSL
• UDI-Device Identifier: 30382904411290
• UDI-Public: 30382904411290
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K081825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 441129
• Device Catalogue Number: 441129
• Device Lot Number: 224293
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/13/2022
• 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