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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while performing a validation run on the wasp instrument that bd vacutainer® boric acid sodium borate/formate c&s urine tubes had a misalignment of the closure making it difficult for the instrument to decap and cap.A cap popped off causing specimen to spill in the analyzer.The customer also noticed some loose closures before sample analysis on the instrument.These reported defects occurred an unspecified number of times.There was no health impact or consequence reported.
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.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
Investigation summary: bd received one video for investigation.The visual evaluation of the video showed the customer¿s failure modes.The device history records could not be reviewed as the lot number is unknown.This complaint has been confirmed for the indicated failure mode: stopper function issues (cocked stopper, stopper pop off, stopper creepout).No definitive root cause could be established for the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported while performing a validation run on the wasp instrument that bd vacutainer® boric acid sodium borate/formate c&s urine tubes had a misalignment of the closure making it difficult for the instrument to decap and cap.A cap popped off causing specimen to spill in the analyzer.The customer also noticed some loose closures before sample analysis on the instrument.These reported defects occurred an unspecified number of times.There was no health impact or consequence 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21537133
• Report Number: 1917413-2025-00200
• Device Sequence Number: 18053134
• Product Code: JSM
• UDI-Device Identifier: 50382903649582
• UDI-Public: (01)50382903649582
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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 Catalogue Number: 364958
• Device Lot Number: UNKNOWN
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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