MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CUSTOM SINGLE DOSE EPIDURAL ANESTHESIA TRAY; EPIDURAL TRAY

Catalog Number 552055

Device Problem Insufficient Information (3190)

Patient Problems Meningitis (2389); Test Result (2695)

Event Date 02/12/2015

Event Type  Injury  

Event Description

As reported by the user facility: reports a patient developed meningitis within 12 hours after a procedure.The patient had a form of meningitis that was from streptococcus salivarius.This is typically an oral bacteria that is passed by droplets.No one in the case remembers coughing or sneezing on the patient.The patient had a dental procedure 10 days prior.White blood cell (wbc) was elevated when admitted to the hospital.The pre-op and post-op vitals were stable without a fever notated.The procedure itself was unremarkable.No patients that were treated since then have reported any illnesses.Follow-up correspondence with the reporting facility indicated it is unclear as to how the patient contracted the meningitis.There was either a droplet exposure in the room during her epidural steroid injection or she obtained the bacteria during a dental procedure she had a couple of days before.Exact lot is unknown; potential lot numbers reported: lot # 0061392734 - mgf: 09/2014 - expiration: 09/30/2016.

Manufacturer Narrative

(b)(4).There were no samples received for evaluation in connection with the reported incident.A thorough review of the sterilization records was conducted for the reported lot numbers.This included a review of the biological indicator (bi) and bacteria endotoxin (lal) test results.All results were found to be acceptable and within specification.No abnormalities were noted that could have potentially contributed to the reported event.Review of the discrepancy management system database performed for the reported lot numbers did not reveal any abnormalities or nonconformances of this nature.A historical review of the customer complaint database, dating back three years, revealed no other reports of this nature against any of our epidural / spinal tray products.There is no current information available to suggest that the b braun product caused or contributed to the reported event.If additional pertinent information that impacts the result of the investigation becomes available, a follow-up report will be filed.

• Brand Name: CUSTOM SINGLE DOSE EPIDURAL ANESTHESIA TRAY
• Type of Device: EPIDURAL TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4617670
• MDR Text Key: 16172839
• Report Number: 2523676-2015-00080
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K840179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 552055
• Device Lot Number: 0061404028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other