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 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown, device manufacture date: unknown.(b)(4).Investigation summary: no samples or photos were returned by the customer in support of this complaint.Lot number is unknown.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because no samples or photos were returned, and lot number is unknown.Lot number is unknown; therefore, no retention samples are available.Bd was not able to identify a root cause for the indicated failure mode.The device history records could not be reviewed as the lot number is unknown.

Event Description

It was reported with use of the bd vacutainer® urine collection cups resulted in a needle stick injury - post use.The following information was provided by the initial reporter.The customer stated: "there was a needle stick injury with the use of the bd urine cup.".

Manufacturer Narrative

H.6.Investigation: 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.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported with use of the bd vacutainer® urine collection cups resulted in a needle stick injury - post use.The following information was provided by the initial reporter.The customer stated: "there was a needle stick injury with the use of the bd urine cup.".

• 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: 11302385
• MDR Text Key: 231006614
• Report Number: 1917413-2021-00077
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other