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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd¿ universal viral transport kit, 3 ml vial there was a discrepancy in the expiration date on the vials and coc packaging list.The following information was provided by the initial reporter: it was reported that there was a discrepancy in the expiration date on the vials and coc packaging list.Customer problem: uvt 220220 labeling issue - discrepancy in exp date on vials and coc / packing list.Customer responded providing 2 photos - please see attached, and the following responses: lot number and expiration date printed on the vials; lot n030681 expiration 2022-04-30.Lot number and expiration date printed on the packing list; lot n030681 expiration 2022-05-31.See also attached cofc.".
Event or Problem Description
It was reported that while using bd¿ universal viral transport kit, 3 ml vial there was a discrepancy in the expiration date on the vials and coc packaging list.The following information was provided by the initial reporter: it was reported that there was a discrepancy in the expiration date on the vials and coc packaging list.Customer problem: uvt 220220 labeling issue - discrepancy in exp date on vials and coc / packing list.Customer responded providing 2 photos - please see attached, and the following responses: lot number and expiration date printed on the vials; lot n030681 expiration 2022-04-30 lot number and expiration date printed on the packing list; lot n030681 expiration 2022-05-31 see also attached cofc".
Additional Manufacturer Narrative
H.6 investigation summary: this memo serves to summarize findings on your recent complaint 5520009 on product 220220 (vial universal viral transport), lot number n03068100, where it was observed that there was a discrepancy between the expiration date listed on the product certificate/kit label and the tube label.Event description: " uvt 220220 labeling issue." 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 indicate a discrepancy between the tube label and the rest of the product labeling.Sample analysis: the photos provided did show the noted defect.The date on the tube does not match the date on the product labeling.The retention samples could not be inspected as the complaint was received months after the product had been expired and the retention samples were no longer available.Evaluations results: based on the investigation, the photos showed the noted defect.While there is no systemic failure in the manufacturing process, a revision to the manufacturing sop has been completed to increase controls around the assignment of expiration date and reduce the possibility for data entry errors.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed on the photos.Other than the revision to the sop, no further actions will be taken as confirmed trend has not been identified.Bd will continue to monitor for trending.The risk to the end user is minimal as the discrepant date is shorter than the correct date.

• 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: 15135695
• Report Number: 1119779-2022-01050
• Device Sequence Number: 17473649
• Product Code: JSM
• UDI-Device Identifier: 30382902202203
• UDI-Public: 30382902202203
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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 Expiration Date: 05/31/2022
• Device Model Number: 220220
• Device Catalogue Number: 220220
• Device Lot Number: N03068100
• 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: 07/05/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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