MAUDE Adverse Event Report: BECTON DICKINSON; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Device Problems Off-Label Use (1494); Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 05/15/2017

Event Type  malfunction  

Event Description

The clinic ordered one pack of gray top urine tubes.The store room mistakenly filled the order with the incorrect item and sent the clinic one pack of gray top sodium fluoride blood tubes.Not realizing the mistake, the clinic then collected patients' urine specimens into the incorrect tube type and sent them to the lab for urine culture.The tube manufacturer, becton dickinson, was notified of the problem and the organization filed a formal complaint that the two different tube types look so similar (the appearance contributed to the mix up).Bd sent a message that the sodium fluoride tube was not acceptable for urine collection.

• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 6962661
• MDR Text Key: 89839026
• Report Number: 6962661
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2017
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1