MAUDE Adverse Event Report: BD BD LUER-LOK ACCESS DEVICE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Device Problem Connection Problem (2900)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2015

Event Type  malfunction  

Event Description

The luer fitting connection was so tight, staff were not able to get it disconnected.They had to destroy the fitting in order to get the connection to come apart.Vacutainer stuck to patient's cvc lumen.

• Brand Name: BD LUER-LOK ACCESS DEVICE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BD; 5859 farinon drive sutie 200; san antonio TX 78249
• MDR Report Key: 5356800
• MDR Text Key: 35513883
• Report Number: 5356800
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2016
• 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
• Patient Age: 2 YR