MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE; TRANSPORT CULTURE MEDIUM

Model Number	364958
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube, the device experienced incorrect label information.The following information was provided by the initial reporter.The customer stated: i have the safety data sheet for the bd vacutainer® boric acid tube sodium borate / formate c&s urine tube which indicates the following pictogram, but on the product i still have the pictograms of the old regulations which are no longer applicable since 2015.
Additional Manufacturer Narrative
Investigation: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for incorrect label content with the incident lot was not observed.The visual evaluation of the photos does not show any issues with the shelf label pictogram.Review of the current revision of the vacutainer drawing label shows the correct label artwork was printed and applied to the shelf pack.Bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube, the device experienced incorrect label information.The following information was provided by the initial reporter.The customer stated: i have the safety data sheet for the bd vacutainer® boric acid tube sodium borate / formate c&s urine tube which indicates the following pictogram, but on the product i still have the pictograms of the old regulations which are no longer applicable since 2015.

• Brand Name: BD VACUTAINER BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
• Common Device Name: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 12124420
• Report Number: 1917413-2021-00582
• Device Sequence Number: 19715195
• Product Code: JSM
• UDI-Device Identifier: 50382903649582
• UDI-Public: 50382903649582
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 364958
• Device Catalogue Number: 364958
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1