MAUDE Adverse Event Report: BD DISTRIBUTION CENTER BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED FLEXIBLE MINITIP; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Model Number	220531
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd¿ universal viral transport kit, 3 ml, flocked flexible minitip label dates are incorrect.The following information was provided by the initial reporter: reported uvt media has expiration date of june 30 2022 and kit label has expiration date of 10/31/23.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ universal viral transport kit, 3 ml, flocked flexible minitip label dates are incorrect.The following information was provided by the initial reporter: reported uvt media has expiration date of june 30 2022 and kit label has expiration date of 10/31/2023.
Additional Manufacturer Narrative
H6 investigation summary: this memo serves to summarize findings on your recent complaint (b)(4) on product 220531 (kit uvt 3ml with flocked flex minitip), lot number n20282900, where it was observed that there was a dating discrepancy between the tube and kit expiration dates.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 does not indicate any manufacturing issues.Sample analysis: the photos provided did show a tube with a different expiration date than that of the kit.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, the photo did show a tube with a different date.However, the lot number of the tube was not clearly seen in the photo.Looking at the lot number digits that are visible and comparing that to the lot numbers packaged in this product, the only lot that matches it was produced on dec 30th, 2020.This kit lot was manufactured on may 2nd, 2022.The tube lot could not have been packaged in with the kit lot.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.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 on the photo.No further actions will be taken as no confirmed trend has been identified.Bd will continue to monitor for trending.

• Brand Name: BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED FLEXIBLE MINITIP
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• Manufacturer (Section D): BD DISTRIBUTION CENTER; 2200 west san bernardino ave; redlands CA 92374
• Manufacturer (Section G): BD DISTRIBUTION CENTER; 2200 west san bernardino ave; redlands CA 92374
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15995720
• Report Number: 3005503186-2022-00003
• Device Sequence Number: 5672435
• Product Code: JSM
• UDI-Device Identifier: 30382902205310
• UDI-Public: 30382902205310
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 220531
• Device Catalogue Number: 220531
• Device Lot Number: N20282900
• 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: 12/01/2022
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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