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

Catalog Number	364958
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 during use with bd vacutainer® boric acid sodium borate/formate c&s urine tube contamination of the tube was suspected.The following information was provided by the initial reporter: over the past few days, the laboratory has been isolating burkholderia from urine samples, which were confirmed to be sterile after re-checking.They are currently investigating, and one of their leads may be a contamination of batch 3073801 of borate tubes.
Event or Problem Description
It was reported that during use with bd vacutainer® boric acid sodium borate/formate c&s urine tube contamination of the tube was suspected.The following information was provided by the initial reporter: over the past few days, the laboratory has been isolating burkholderia from urine samples, which were confirmed to be sterile after re-checking.They are currently investigating, and one of their leads may be a contamination of batch 3073801 of borate tubes.
Additional Manufacturer Narrative
H10: manufacturer narrative: bd had not received samples or photos for investigation.Therefore, 100 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to sterility as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode sterility.Bd was not able to identify a root cause for the indicated failure mode.

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17981596
• Report Number: 1917413-2023-01056
• Device Sequence Number: 2467138
• Product Code: JSM
• UDI-Device Identifier: 50382903649582
• UDI-Public: (01)50382903649582
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: 08/31/2024
• Device Catalogue Number: 364958
• Device Lot Number: 3073801
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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