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

Catalog Number	220529
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This site is an oem manufacturing site.Therefore, bd corporate headquarters in sparks, md has been listed in sections d.3.And g.1.And the sparks fda registration number has been used for the manufacture report number.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#:n30454700, d4.Medical device expiration date: 28-feb-2025, h4.Device manufacture date: 04-dec-2023.H3.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 prior to use of the bd universal viral transport kit, 3 ml, flocked minitip had an unspecified number of swabs that had the printed date on the swab's wrapper (peel pouch) show that it expired before the expiration date printed on the outside package.No health impact or consequence reported.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2024-00538 was sent in error.Bd is not the legal manufacturer, and the product is not subject to adverse event assessment and reporting by bd.
Event or Problem Description
It was reported prior to use of the bd universal viral transport kit, 3 ml, flocked minitip had an unspecified number of swabs that had the printed date on the swab's wrapper (peel pouch) show that it expired before the expiration date printed on the outside package.No health impact or consequence reported.

• Brand Name: BD UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED MINITIP
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19661233
• Report Number: 1119779-2024-00538
• Device Sequence Number: 15130463
• Product Code: JSM
• UDI-Device Identifier: 30382902205297
• UDI-Public: (01)30382902205297
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 02/25/2025
• Device Catalogue Number: 220529
• Device Lot Number: N30463700
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• 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