MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER URINE COLLECTION KIT; URINE SPECIMEN CUP

Catalog Number 6630-01-505-9384

Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/21/2016

Event Type  Other  

Event Description

Pt removed yellow "do not remove label" sticker no lid of urine specimen cup and poked himself with the needle inside, causing break in his skin.Although sticker prompts user to not remove sticker, the sticker itself is a contrasting color to the lid therefore appears 'inviting'.Font on sticker is very small.Drawing on sticker is very light.Both of these may be difficult for aging eyes to read, understand.Dose or amount: 1 cup, frequency: ud.Diagnosis: urine collection.

• Brand Name: BD VACUTAINER URINE COLLECTION KIT
• Type of Device: URINE SPECIMEN CUP
• Manufacturer (Section D): BECTON DICKINSON; franklin lakes NJ
• MDR Report Key: 6030665
• MDR Text Key: 57707350
• Report Number: MW5065408
• Device Sequence Number: 1
• Product Code: FMH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 6630-01-505-9384
• Device Lot Number: VARIOUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 84