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 04/29/2021

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.

Event Description

It was reported when using the bd vacutainer® urine collection cups there was a needle stick injury - post use (collection cup.Luer-lok access device or straw).The following information was provided by the initial reporter.The customer stated: "there was a needlestick injury with a urine collection cup.Needle stick took place after use.Rn was exposed to patient's urine.Needle broke the skin of rn's finger.Rn was taken to the er for post exposure testing.Results are currently negative with repeat blood draw still pending.".

Event Description

It was reported when using the bd vacutainer® urine collection cups there was a needle stick injury - post use (collection cup.Luer-lok access device or straw) the following information was provided by the initial reporter.The customer stated: "there was a needlestick injury with a urine collection cup.Needle stick took place after use.Rn was exposed to patient's urine.Needle broke the skin of rn's finger.Rn was taken to the er for post exposure testing.Results are currently negative with repeat blood draw still pending.".

Manufacturer Narrative

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.

• 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: 11952658
• MDR Text Key: 255927515
• Report Number: 1917413-2021-00495
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• 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: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other