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

Catalog Number 560272

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.A representative from b.Braun medical inc.Is attempting to obtain additional details from the reporting facility regarding each case.Per the drug instruction sheets contained in the kit for the reported product catalog number, bradycardia is cited as a potential adverse reaction to the administration of the drug.Specifically, "high doses, or inadvertent intravascular injection, may lead to high plasma levels and related depression of the myocardium, decreased cardiac output, bradycardia, heart block, ventricular arrhythmias, and, possibly, cardiac arrest," and "if not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis plus myocardial depression from the direct effects of the local anesthetic may result in cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation, or cardiac arrest." review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.There were no other reports of this nature against the reported lot number.The investigation into this reported event is ongoing.All available information has been forwarded to the drug manufacturer for further evaluation.Following the receipt of additional information and/or completion of the investigation a follow-up report will be filed.

Event Description

As reported by the user facility: event # 4: reports five cases of profound bradycardia within the past two weeks, including three cases of asystole.In one of the cases, the patient was in the operating room with lateral positioning.Patient had no symptoms of high spinal prior to the event.Patient dob: (b)(6).No further information is available at this time regarding the remaining cases.

Manufacturer Narrative

The reported product catalog kit number contains the following drugs: 2ml marcaine bupivacaine hydrochloride 0.75% with dextrose 8.25%; 1ml epinephrine 0.1%; 5ml lidocaine 1%.It is unknown which drugs were used in each event.Multiple follow-up attempts with the reporter to obtain additional information were unsuccessful.The actual devices involved in the reported incident were not returned for evaluation.The drug manufacturer reviewed the batch records for all involved drug lots contained in the reported kit.There were no discrepancies noted that may have contributed to an issue of this nature.Quality assurance testing performed during manufacturing was acceptable and met all specification requirements.Based on the results of this investigation, a definitive conclusion could not be made regarding the cause of the reported events.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.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5293272
• MDR Text Key: 33465953
• Report Number: 2523676-2015-00601
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

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?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 560272
• Device Lot Number: 0061430495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2015
• 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): Life Threatening; Required Intervention