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

Catalog Number 333868

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/05/2017

Event Type  malfunction  

Event Description

Spinal places for block during surgery.Blockade was partially ineffective.The provider needed to redo the block to successfully provide intraoperative analgesia.Manufacturer response for pencan spinal needle tray, (brand not provided) (per site reporter).Nature of marcaine and yes it suggests that the drug is unstable.

• 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: 7147354
• MDR Text Key: 95814534
• Report Number: 7147354
• 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: Patient
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 333868
• Other Device ID Number: 04046964180859
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2017
• Event Location: Other
• Date Report to Manufacturer: 12/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR