MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® URINE COLLECTION CUPS; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364975

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/19/2023

Event Type  Injury  

Event Description

Report 1 of 2.It was reported that while using the bd vacutainer® urine collection cups that there was a needle stick injury, post use.The following information was provided by the initial reporter: hazard, injury or erroneous results details an emergency dept nurse felt the need to push her finger through the yellow label of the urine cup and sticking her finger.Does any patient or technician was injured or affected by this defect? not a defect; employee put their finger in the hole where the transfer tube goes.If yes, did they receive any post exposure treatment or had any adverse impact? employee health following as a needlestick occurrence.How many individuals were affected? 2.What testing, treatment and/or medical intervention (if any) were done to the affected individuals? being followed by employee health for a needle stick occurrence.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details an emergency dept nurse felt the need to push her finger through the yellow label of the urine cup and sticking her finger.Customer states - the nurse manager and clinical educator did train all clinical teams, however it seems that an emergency dept nurse felt the need to push her finger through the yellow label of the urine cup and sticking her finger.

Manufacturer Narrative

D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for evaluation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode needle stick.Bd was not able to identify a root cause for the indicated failure mode.See h.10.

Event Description

It was reported when using the bd vacutainer® urine collection cups the nurse push her finger through the yellow label of the urine cup and sticking her finger.Employee sent to employee health any testing or intervention has not yet been reported.This is the 1st of 2 events.The following information was provided by the initial reporter.The customer stated: customer problem: the nurse manager and clinical educator did train all clinical teams, however it seems that an emergency dept nurse felt the need to push her finger through the yellow label of the urine cup and sticking her finger.

• Brand Name: BD VACUTAINER® URINE COLLECTION CUPS
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17466796
• MDR Text Key: 320474595
• Report Number: 2243072-2023-01378
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• 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): Other