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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
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.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported when using an bd vacutainer® urine complete cup kit during the process of preparing or completing transfer to the collection tube nurses are accidently inserting their finger in the recessed sharps area, which caused a needlestick injury.The following information was provided by the initial reporter.The customer stated: -customer problem: customer reports needlestick injuries while using bd urine collection cups.-steps taken with customer/troubleshooting: per pir3068079, customer states nursing staff is experiencing needlesticks with the urine collection cups.Per customer, in the process of preparing or completing transfer to the collection tube nurses are accidently inserting their finger in the recessed sharps area.Two different product numbers were provided, 364956 and 364975.
Event or Problem Description
It was reported when using an bd vacutainer® urine complete cup kit during the process of preparing or completing transfer to the collection tube nurses are accidently inserting their finger in the recessed sharps area, which caused a needlestick injury.The following information was provided by the initial reporter.The customer stated: -customer problem: customer reports needlestick injuries while using bd urine collection cups.-steps taken with customer/troubleshooting: per pir3068079, customer states nursing staff is experiencing needlesticks with the urine collection cups.Per customer, in the process of preparing or completing transfer to the collection tube nurses are accidently inserting their finger in the recessed sharps area.Two different product numbers were provided, 364956 and 364975.
Additional Manufacturer Narrative
H.6 investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.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.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18066342
• Report Number: 1917413-2023-01114
• Device Sequence Number: 7572613
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: (01)50382903649568
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/07/2023

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 Catalogue Number: 364956
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Other
• Patient Sex: Unknown