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

Model Number	441091
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that there was contamination on bd viper¿ system.There was one occurrence in this event with no patient impact.The following information was provided by the customer: "for the past three days, the instrument has been contaminated with gc.The customer has tried to extensively decontaminate the instrument but this is still showing up, and they are now requesting support on this.
Additional Manufacturer Narrative
Medical device expiration date: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary:the complaint alleges the bd viper xtr instrument (catalog number 441091 and serial number: (b)(6)) had "false positives".Customer reported that for the past few days their instrument has been contaminated with gc.The customer has attempted to decontaminate the instrument but are unable to resolve the issue.Customer requests further assistance.Application specialists instructed the customer to perform 3 rounds of deep cleaning, including lab touch points, and to perform em testing to confirm if cleaning is successful.After multiple rounds of cleaning, the customer confirmed that the contamination issue has been resolved.This complaint is unconfirmed as the complaint alludes to a contamination issue and the instrument is operating to bd specifications.No samples were expected to be received as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Review of device history record for instrument (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the complaint is unconfirmed, thus a dhr review would yield no useful information.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.
Event or Problem Description
It was reported by the customer that there was contamination on bd viper¿ system.There was one occurrence in this event with no patient impact.The following information was provided by the customer: "for the past three days, the instrument has been contaminated with gc.The customer has tried to extensively decontaminate the instrument but this is still showing up, and they are now requesting support on this.".

• Brand Name: BD VIPER¿ SYSTEM
• 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: 15419844
• Report Number: 1119779-2022-01190
• Device Sequence Number: 2786097
• Product Code: LSL
• UDI-Device Identifier: 00382904410919
• UDI-Public: 00382904410919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 441091
• Device Catalogue Number: 441091
• 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: 08/31/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• 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