MAUDE Adverse Event Report: B. BRAUN MEDICAL INC.; ANESTHESIA CONDUCTION KIT

Model Number ES1725KFX

Device Problem Failure to Advance (2524)

Patient Problem No Code Available (3191)

Event Date 11/23/2015

Event Type  malfunction  

Event Description

While doing a routine combined spinal epidural, glass syringe malfunctioned by not sliding easily even though it was completely lubricated with sterile saline throughout the barrel from the cse kit.This resulted in alteration of sensation of the bouncing of the plunger when advancing the tuohy needle and ultimately inadvertent dural puncture and leakage of csf from the tuohy needle.Attempted to thread the epidural catheter into the subdural space to leave in for 24 hours to decrease risk for post-puncture headache but patient began to complain of paresthesias on the right, so catheter and needle were removed completely.

• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon boulevard; allentown PA 18109
• MDR Report Key: 5322136
• MDR Text Key: 34206409
• Report Number: 5322136
• Device Sequence Number: 1
• Product Code: CAZ
• 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: Patient
• Type of Report: Initial
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/01/2017
• Device Model Number: ES1725KFX
• Device Lot Number: 61450447
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR