MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN; SPINAL ANESTHESIA KIT

Model Number 333851

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Numbness (2415)

Event Date 02/16/2018

Event Type  malfunction  

Event Description

Partial spinal achieved, doctor.Had to turn case into general anesthesia due to partial numbness.Suspect meds are ineffective in spinal kit.Company notified.Per site reporter: manufacturer for spinal kit is contacting their quality department to see how many we can send back to them.They will not be able to send replacements only credit since the medication for the trays is on backorder.

• Brand Name: PENCAN
• Type of Device: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7295760
• MDR Text Key: 100940900
• Report Number: 7295760
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2019
• Device Model Number: 333851
• Device Catalogue Number: 333851
• Device Lot Number: 0061591156
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 33 YR