MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VAGINAL PANEL ON BD COR SYSTEM; MULTIPLE VAGINITIS/VAGINOSIS-ASSOCIATED PATHOGEN NUCLEIC ACID IVD KIT

Catalog Number	443976
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device type: nsu, ouy, pqa 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 during use of bd vaginal panel on bd cor system, a false positive patient result for all targets (candida group, candida glabrata, candida krusei, and trichomonas vaginalis) was obtained.Sample was repeated on bd max¿ system and was only positive for c.Glabrata.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using bd cor¿ vaginal panel (ref.443976) from lot 4289100 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Review of the manufacturing records of individual kit lots components indicates that those lots were manufactured according to specifications and met performance requirements.Customer suspected false positives results when a sample gave positive results for all the targets for the second master mix using bd cor¿ vaginal panel assay, but when repeated on a bd max¿ instrument, the sample tested positive only for the cgla target.Run file from bd cor instrument crm0119, containing the suspected sample, was received for investigation and analysed.Manual pcr curve adjudication was done to sample abot4, identified as the problematic sample by the customer.Targets in the bottom position of the cartridge, namely cgroup (rox channel), ckru (cy5 channel), cgla (vic channel), tv (fam channel) and the internal control (cy5.5 channel) all showed many step dislocations and atypical curves without sigmoidal shape.It is unlikely these are the result of true amplification.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd cor¿ vaginal panel lot used by the customer.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no new hazard was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.
Event or Problem Description
It was reported that during use of bd vaginal panel on bd cor system, a false positive patient result for all targets (candida group, candida glabrata, candida krusei, and trichomonas vaginalis) was obtained.Sample was repeated on bd max¿ system and was only positive for c.Glabrata.There was no report of patient impact.

• Brand Name: BD VAGINAL PANEL ON BD COR SYSTEM
• Common Device Name: MULTIPLE VAGINITIS/VAGINOSIS-ASSOCIATED PATHOGEN NUCLEIC ACID IVD KIT
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22323798
• Report Number: 1119779-2025-00647
• Device Sequence Number: 18345943
• Product Code: OOI
• UDI-Device Identifier: 00382904439767
• UDI-Public: (01)00382904439767(11)241015(17)251021(10)4289100
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223653
• 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): 09/11/2025

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 Expiration Date: 10/21/2025
• Device Catalogue Number: 443976
• Device Lot Number: 4289100
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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