MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINE COLLECTION CUPS; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364975

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd vacutainer® urine collection cups caused a post-use needle stick injury.The following information was provided by the initial reporter: "it was reported that there were needlesticks while using the urine collection cup.(1 of 2).Update: first occurred on (b)(6) 2020 @ 10a in the med/surg unit.Nurse was disposing the cup lid when finger slipped into hole resulting in a needlestick.No medical attention was requested.Per email: we have identified a safety issue related to needlesticks during the use of the bd vacutainer collection cup (364975).Is there a different option in which the needle is in a more protected position?".

Manufacturer Narrative

H.6.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 bd vacutainer® urine collection cups caused a post-use needle stick injury.The following information was provided by the initial reporter: "it was reported that there were needlesticks while using the urine collection cup.(1 of 2).Update: first occurred on (b)(6) 2020 @ 10a in the med/surg unit.Nurse was disposing the cup lid when finger slipped into hole resulting in a needlestick.No medical attention was requested.Per email: we have identified a safety issue related to needlesticks during the use of the bd vacutainer collection cup (364975).Is there a different option in which the needle is in a more protected position?".

• Brand Name: BD VACUTAINER URINE COLLECTION CUPS
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10550428
• MDR Text Key: 207710330
• Report Number: 1917413-2020-00837
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• 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: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364975
• 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