MAUDE Adverse Event Report: B.BRAUN MEDICAL, INC. PENCAN; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Lot Number 61353930

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/17/2014

Event Type  malfunction  

Event Description

A female patient was being prepped for a c-section.Patient was given a spinal anesthetic using spinal tray kit.While they were in a supine position, a foley catheter was inserted.The patient had no analgesia for that procedure.Marcaine in the kit did not provide anesthesia, despite the spinal procedure being performed properly.It was also noted that there was cerebrospinal fluid (csf) in adequate amounts dripping from the spinal needle prior to injection of marcaine.Patient was again positioned for a second attempted spinal anesthetic, and another kit was opened.The anesthetist used anesthesia cart marcaine instead of marcaine from the new kit.The patient instantly had enough anesthesia adequate for the impending surgical procedure.1st kit lot number was 61353930, while the 2nd working kit was lot number was 61345062.Previously in same week (no patient identification at this point) was another kit with lot 61353930 that failed on different patient (didn't provide adequate anesthesia).

• Brand Name: PENCAN
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B.BRAUN MEDICAL, INC.; 824 twelfth avenue; bethlehem PA 18018 352
• MDR Report Key: 3753070
• MDR Text Key: 4483298
• Report Number: 3753070
• Device Sequence Number: 2
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/19/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: 61353930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO.; NO OTHER THERAPIES
• Patient Age: 33 YR
• Patient Weight: 127