MAUDE Adverse Event Report: BECTON, DICKINSON AND CO, BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; TUBES, VIALS, SYSTEMS, SERUM SEPARATION, BLOOD COLLECTION

Model Number 368656

Device Problems Break (1069); Fail-Safe Did Not Operate (4046)

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

Event Date 06/25/2019

Event Type  malfunction  

Event Description

On two separate occasions the device fell apart after use when button was pushed to retract the needle and left the needle unprotected.Fda safety report id # (b)(4).

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATION, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND CO,
• MDR Report Key: 8757449
• MDR Text Key: 150146886
• Report Number: MW5087780
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 368656
• Device Catalogue Number: 368656
• Device Lot Number: 9091626
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR