MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Model Number	220220
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the bd¿ universal viral transport kit, 3 ml vial has been found producing a false negative result.Pcr was used for confirmatory testing.There was no report of patient impact.The following has been provided by the initial reporter: according to the customer's report, a false negative occurred, possibly due to the product.A pcr test was performed with an antigen-positive sample.A negative result was given with a sample transported with uvt.Positive results were given when the sample was stored in saline, and with a measurement of saliva.
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
H.6.Investigation: this statement serves to summarize findings on the recent complaint on product 220220 (vial universal viral transport), lot number unknown, where it was observed that the swab potentially caused a false positive reaction.Event description: " according to the customer's report, a false negative occurred, possibly due to the product.¿ complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the device history record could not be performed as a lot number was not provided.Sample analysis: no photos or returns were available.The retention samples could not be inspected as a lot number was not provided.Evaluations results: based on the investigation, no defect was observed.There is no systemic failure in the manufacturing process.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.No further actions will be taken as no confirmed trend has been identified.Bd will continue to monitor for trending.
Event or Problem Description
It has been reported that the bd¿ universal viral transport kit, 3 ml vial has been found producing a false negative result.Pcr was used for confirmatory testing.There was no report of patient impact.The following has been provided by the initial reporter: according to the customer's report, a false negative occurred, possibly due to the product.A pcr test was performed with an antigen-positive sample.A negative result was given with a sample transported with uvt.Positive results were given when the sample was stored in saline, and with a measurement of saliva.

• Brand Name: BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• 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: 13417241
• Report Number: 1119779-2022-00166
• Device Sequence Number: 4825986
• Product Code: JSM
• UDI-Device Identifier: 30382902202203
• UDI-Public: 30382902202203
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042970
• 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): 06/02/2022

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: 220220
• Device Catalogue Number: 220220
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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