BD VACUTAINER URINE COLLECTION SYSTEM COLLECTION CUP 364957, 364956, 364954, 364975 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-23 for BD VACUTAINER URINE COLLECTION SYSTEM COLLECTION CUP 364957, 364956, 364954, 364975 * manufactured by Bd.

Event Text Entries

[17465834] We are reporting two incidents with this report. In both cases, patients were injured when using the vacutainer urine collection system collection cup. In the first case, a male patient was given the specimen cup and instructed to provide a urine specimen. The rn told the patient to place the lid on the cup when he was done. The patient returned to the room and told his nurse that he was poked when he tried to provide the specimen. The patient had removed the label that covers the transfer device and tried to urinate into that part of the lid. In doing so, the cover that sheathes the needle was pushed back and he was stuck. In the second case, a female patient was given similar instructions. The patient told the nurse she was stuck on her finger when she tried to push down on the rubber covering that sheathes the needle (the patient had removed the label and urinated into the transfer well on the specimen lid. The manufacturer made a change to the label on this device's container. Previously, the label had a large red circle with a slash through it along with lettering that informed the patient not to remove the label. In december of 2009, the label was changed to show a finger poking into the well with a red "x" through it and three numbered photos for how staff are to use the device to obtain a specimen in a tube from the cup. Patients are misreading the label despite staff's verbal instructions on how to use the device.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1623353
• MDR Report Key: 1623353
• Date Received: 2010-02-23
• Date of Report: 2010-02-23
• Date of Event: 2010-02-19
• Report Date: 2010-02-23
• Date Reported to FDA: 2010-02-23
• Date Added to Maude: 2010-03-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BD VACUTAINER URINE COLLECTION SYSTEM COLLECTION CUP
• Generic Name: CUP, URINE COLLECTION
• Product Code: LIO
• Date Received: 2010-02-23
• Model Number: 364957, 364956, 364954, 364975
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BD
• Manufacturer Address: 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-02-23