MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COMPLETE CUP KIT; TRANSPORT CULTURE MEDIUM

Catalog Number	364956
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore 10 retention samples were visually inspected with no issues being identified.Additionally, further functional testing was performed and all samples tested within specification limits; no defects were found.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, needlestick based on the testing performed.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 the bd vacutainer® urine complete cup kit that the needle remained in the vacutainer tube when the sample was removed from the urine collection cup.A healthcare worker received a minor abrasion on their thumb when handling the vacutainer tube.Post exposure blood work was obtained and tested.There was no health impact or consequence reported.The following information was provided by the initial reporter: "when an employee went to remove the vacutainer tube from the urine collection cup lid needle, the needle came out of the lid.Customer wasn't expecting the needle to be on top of a tube, and went to put the tube down which resulted in a minor abrasion on her thumb.If exposure occurred was there any post exposure testing or medical intervention? yes, the bloodwork is underway, and the patient information and results are available.".

• Brand Name: BD VACUTAINER® URINE COMPLETE CUP KIT
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19262394
• Report Number: 1917413-2024-00385
• Device Sequence Number: 6614461
• Product Code: JSM
• UDI-Device Identifier: 00382903649563
• UDI-Public: (01)00382903649563
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 364956
• Device Lot Number: 4005726
• 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: 04/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown