MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE; EVACUATED URINE SPECIMEN CONTAINER IVD, NO ADDITIVE

Catalog Number	368501
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but 6 photos were provided for investigation.The photos were reviewed and the indicated failure mode for damaged tube was observed.Due to a limited information retained tubes testing could not be replicated using centrifuge, as customer's user settings are unknown.Visual examination of 100 retained tubes from this lot number did not identify any further defective tubes.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 damaged tube.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 when using the bd vacutainer® z (no additive) plus urine tube, the tube broke in the centrifuge.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE
• Common Device Name: EVACUATED URINE SPECIMEN CONTAINER IVD, NO ADDITIVE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19754809
• Report Number: 9617032-2024-01068
• Device Sequence Number: 20484662
• Product Code: FMH
• UDI-Device Identifier: 30382903685012
• UDI-Public: (01)30382903685012
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

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: 08/31/2025
• Device Catalogue Number: 368501
• Device Lot Number: 4096597
• 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: 06/21/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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