MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN SPINAL TRAYS

Model Number P25BK

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Event Description

As reported by the user facility: event #6: reports of 6 cases of severe bradycardia, with one case of asystole.The pts were treated with atropine.The reporter indicated this happened this past week with different doctors.The only thing noticed new with this tray was a new vial of marcaine bupivacaine, same concentration, different look.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report #(b)(4).The actual device involved in the reported incident was not returned for evaluation.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances noted during in-process or final product inspection.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 info has been forwarded to the drug mfr for further evaluation.Following the receipt of additional info and/or completion of the investigation a follow-up report will be filed.

• Brand Name: PENCAN SPINAL TRAYS
• Type of Device: SPINAL TRAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 3835994
• MDR Text Key: 4394327
• Report Number: 2523676-2014-00167
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932569
• 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: 05/09/2014

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: 07/31/2015
• Device Model Number: P25BK
• Device Catalogue Number: 333851
• Device Lot Number: 0061363156
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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): Life Threatening; Required Intervention