MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. CUSTOM SPINAL ANESTHESIA TRAY; SPINAL TRAY

Catalog Number 560563

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Therapeutic Effects, Unexpected (2099)

Event Date 02/18/2015

Event Type  Injury  

Event Description

As reported by the user facility: reports a lack of anesthetic effect.When the surgeon began cutting through skin, the patient yelled "ouch" and fell off the table.

Manufacturer Narrative

(b)(4).During a follow-up with the facility, the reporter stated that no additional information was available.The reporter provided contact information for the anesthesia supervisor.Multiple follow-up attempts to anesthesia supervisor to obtain additional information were unsuccessful.The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough evaluation could not be performed and no specific conclusions can be drawn.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformance of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.There were no other reports of this nature against the reported lot number.All available information has been forwarded to the drug manufacturer.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: CUSTOM SPINAL ANESTHESIA TRAY
• Type of Device: SPINAL TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA 18109 934
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109-9341 ; 6102660500
• MDR Report Key: 4606391
• MDR Text Key: 5468270
• Report Number: 2523676-2015-00082
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 560563
• Device Lot Number: 0061397266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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