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

Catalog Number 333851

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2017

Event Type  malfunction  

Event Description

Failure of a spinal anesthetic, suspected meds in kit were not effective- possibly due to temperature of medication during transport.Package states to store at 68-77 degrees f.Was evident that spinal did not work, patient never felt numbness in legs or abdomen.Anesthesia converted to general anesthesia.Hospital has had several cases of ineffective local anesthesia delivery.Additional patient safety events for this issue: spinal anesthesia given, yet numbness did not take effect.Anesthesia was then converted to general anesthesia ¿ given by doctor.No harm to patient.The patient was to receive spinal anesthesia.After placed, did not achieve effective numbness.Was determined that spinal was ineffective.Anesthesia was changed to general anesthesia.No harm done, but increased wake up time exposed to side effects of gen anesthesia.Failed spinal anesthesia, then changed to general anesthesia.Patient could feel and was not numb, kept comfortable and changed to general anesthesia.Patient was given spinal anesthesia and was found to be inadequate.Patient had sensation feeling from waist down.Anesthesia was then converted to gen anesthesia, no harm done, just exposed patient to all side effects of general anesthesia.

• Brand Name: PENCAN
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6510842
• MDR Text Key: 73349759
• Report Number: 6510842
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 333851
• Device Lot Number: 0061539153
• 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: 03/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2017
• 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
• Patient Age: 58 YR