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

Catalog Number 364957

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/23/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that a needlestick injury occurred after collection with a bd vacutainer® urine complete cup kit.The following information was provided by the initial reporter: (2 of 2 complaints).Nurse was walking to sharps container located in soiled utility.Sharps container in patient¿s room not large enough to accept cup lid.While walking, nurse was trying to use glove to cover lid & finger slipped into hole resulting in needlestick.

Manufacturer Narrative

Investigation: bd had not received samples or photos from the customer 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.

Event Description

It was reported that a needlestick injury occurred after collection with a bd vacutainer® urine complete cup kit.The following information was provided by the initial reporter: (2 of 2 complaints) nurse was walking to sharps container located in soiled utility.Sharps container in patient¿s room not large enough to accept cup lid.While walking, nurse was trying to use glove to cover lid & finger slipped into hole resulting in needlestick.

• 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
• MDR Report Key: 10544039
• MDR Text Key: 207299171
• Report Number: 1917413-2020-00823
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• PMA/PMN Number: K024240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 364957
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other