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

Model Number 560436

Device Problems Device Operates Differently Than Expected (2913); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Code Available (3191)

Event Date 02/09/2018

Event Type  malfunction  

Event Description

Female patient underwent c-section at (b)(6) due to worsening preeclampsia.Spinal anesthesia was attempted twice, but was not found to be adequate.The patient then required general anesthesia for the delivery of the infant via c-section.Around the time of this event, anesthesia providers at an outside hospital in the area reported anesthesia issues with bupivacaine custom spinal kits used at this user facility.Anesthesia reviewed the lot #s used on this patient that had 2 failed spinals.Facility proceeded to pull all spinal kits with the lot number suspected to be the issue from hospital stock.The kits in question are a custom spinal kit that b.Braun produces for this facility.Bupivacaine is added to this custom kit.B.Braun was notified of this serious issue.There is a temperature warning label on the kit.However, there is significant concern that the temperature requirement for bupivacaine is not being met during transportation.

• Brand Name: DESIGN OPTIONS
• Type of Device: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7356674
• MDR Text Key: 103012510
• Report Number: 7356674
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 560436
• Device Catalogue Number: 560436
• Device Lot Number: 0061576755
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Age: 36 YR
• Patient Weight: 74