MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL; SEE H.10

Model Number	220220
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd¿ universal viral transport kit, 3 ml vial that there was contamination.The following information was provided by the initial reporter: the customer found foreign matter in the media which discolored it.
Additional Manufacturer Narrative
Common device name: culture media, non-propagating transport.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 while using the bd¿ universal viral transport kit, 3 ml vial that there was contamination.The following information was provided by the initial reporter: the customer found foreign matter in the media which discolored it.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes, d9: returned to manufacturer on: 2023-02-03.H.6.Investigation summary: this memo serves to summarize findings on your recent complaint (b)(4) on product 220220 (vial universal viral transport), lot number n20300700, where it was observed that there was one tube that appeared to be contaminated with mold.Event description: " the customer found foreign matter in the media which discolored it." 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 device history record did not indicate any manufacturing issues.Sample analysis: the photos and returns provided did show the noted defect.An inspection of the retention samples did not show the noted defect.Evaluations results: based on the investigation, the noted defect was observed in both the photos and return sample inspection.The retention samples were satisfactory.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed on the photos and return.A review of complaints does not indicate that a trend is present.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.No further action will be taken as this is considered to be an isolated incident.

• Brand Name: BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL
• Common Device Name: SEE H.10
• 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: 16363038
• Report Number: 1119779-2023-00127
• Device Sequence Number: 7390531
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: 10/31/2023
• Device Model Number: 220220
• Device Catalogue Number: 220220
• Device Lot Number: N20300700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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