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

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	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® boric acid sodium borate/formate c&s urine tube foreign matter(coring) was found in the tubes in an unspecified amount of patient samples.At least 10 patient samples were affected.There was no health impact or consequences reported.
Additional Manufacturer Narrative
E1.Initial reporter addr 1: (b)(6).There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 3291583.D4.Medical device expiration date: 30-apr-2025.H4.Device manufacture date: 18-oct-2023.Quantity: unspecified.D4.Medical device lot #: 3079438.D4.Medical device expiration date: 30-jun-2025.H4.Device manufacture date: 19-dec-2023.Quantity: unspecified.D4.Medical device lot #:3358570.D4.Medical device expiration date: 30-apr-2025.H4.Device manufacture date: 18-oct-2023.Quantity: unspecified.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: b5.Describe event: it was reported while using bd vacutainer® boric acid sodium borate/formate c&s urine tube, foreign matter (coring) was found in twenty-four (24) samples.There was no health impact or consequences reported.D4.Medical device lot#: 3076438, d4.Medical device expiration date: 30-sep-2024, h4.Device manufacture date: 17-mar-2023.D4.Medical device lot#: 3353570, d4.Medical device expiration date: 30-jun-2025, h4.Device manufacture date: 19-dec-2023.Investigation summary: 4 photos were provided for investigation.The photos were reviewed and the indicated failure mode for coring was observed.100 retention samples from each lot from bd inventory were visually inspected with no issues observed.Additionally, 10 retain samples from each lot were draw tested and no coring was observed in the samples tested.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 has been confirmed for the indicated failure mode coring based on the photos provided.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported while using bd vacutainer® boric acid sodium borate/formate c&s urine tube, foreign matter (coring) was found in twenty-four (24) patient samples.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19954937
• Report Number: 1917413-2024-00731
• Device Sequence Number: 8801745
• Product Code: JSM
• UDI-Device Identifier: 50382903649582
• UDI-Public: (01)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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 06/30/2025
• Device Catalogue Number: 364958
• Device Lot Number: 3353554
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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