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

Catalog Number 364956

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/04/2023

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 327297668
• Report Number: 1917413-2023-01114
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: (01)50382903649568
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364956
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other