MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367344

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2019

Event Type  malfunction  

Event Description

When the nurse was using a green 21 gauge butterfly needle to obtain blood from a patient, the nurse did not notice any defect in the device, but when the nurse placed the needle in the vein, then the blood return was sluggish and the nurse couldn't get the blood to flow into the blood collection tube set in the vacutainer.The blood dripped from the tubing just above the hub used to connect the syringe at the vacutainer.The device was saved and will be returned (offered for return) to the manufacturer.Manufacturer response for butterfly needle, (brand not provided) (per site reporter) : our materials management department will alert the manufacturer that the device is available to retrieve.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 8900833
• MDR Text Key: 154548841
• Report Number: 8900833
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2019,07/17/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 367344
• Device Catalogue Number: 367344
• Device Lot Number: 8253781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA