MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EPIDURAL KIT

Lot Number 0061582603

Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem No Information (3190)

Event Date 03/24/2018

Event Type  malfunction  

Event Description

During a labor epidural: an 18-gauge 3-1/2 epidural tipped needle was advanced into the epidural space from a midline.A multiorifice catheter was inserted to less than 10cm and resistance was met, then rotated needle 90 degrees to the right and attempted to advance catheter and still met resistance.Catheter was then withdrawn at that time and the blue tip was not intact.Provider unsure if blue tip broke during insertion or was never there.Therapy start date: (b)(6) 2018.Therapy end date: (b)(6) 2018.Diagnosis or reason for use: labor epidural.

• Brand Name: EPIDURAL KIT
• Type of Device: EPIDURAL KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 7411491
• MDR Text Key: 105152418
• Report Number: MW5076389
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2018
• Device Lot Number: 0061582603
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 66