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

Model Number 333851

Device Problems Inadequate Storage (1600); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2017

Event Type  malfunction  

Event Description

The medsun report completed by the clinical coordinator for anesthesia: failure of spinal anesthesia, suspect meds in spinal tray have been stored too low of temperature during winter months.Have caused medications to be ineffective for achievement of spinal anesthesia.The patient safety report completed by the same person: failed spinal partial spinal anesthesia obtained even though physician confirms correct placement of meds.More marcaine/bupivacaine used on surgical field, more sedation given iv.All kits with this lot number pulled from shelves.The product was also pulled from our distribution center in the hospital.This facility has had more than 5 similar events with this product (anesthesia kit) within the last 2 months.The manufacturer has been notified.The facility has offered to return product for the manufacturer's investigation/analysis, but the manufacturer has refused to accept affected product for return examination/evaluation.Patients who have had ineffective spinals have had their cases converted to general anesthesia, which is a higher level of care.The staff are unable to determine which kits have affected product until the spinal is given and the patient does not experience numbing.

• 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: 6506994
• MDR Text Key: 73254250
• Report Number: 6506994
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2018
• Device Model Number: 333851
• Device Catalogue Number: 333851
• Device Lot Number: 0061543682
• 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: 04/19/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2017
• 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: 32 YR