MAUDE Adverse Event Report: B. BRAUN B. BRAUN; EPIIDURAL CATHETER

Model Number ES1725KFX

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 05/16/2018

Event Type  malfunction  

Event Description

Anesthesiologist discovered product defective; no lumen in epidural catheter noted.

• Brand Name: B. BRAUN
• Type of Device: EPIIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN; 904 postal road; east allentown PA 18109
• MDR Report Key: 7691215
• MDR Text Key: 114422344
• Report Number: 7691215
• Device Sequence Number: 1
• Product Code: BSO
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/06/2018

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: No Information
• Device Model Number: ES1725KFX
• Device Lot Number: 006159 5500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2018
• Distributor Facility Aware Date: 05/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2018
• 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 Age: 28 YR