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

Model Number 333192

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

Espocan combined spinal and epidural anesthesia tray was missing the 25 ga.X 1-1/2 inch needle.The doctor was in the process of placing and epidural on a labor and delivery patient when he noticed the needle was not in the cse tray and thus had to open a new tray.Most recently it has been noted that subsequent trays have similar issues with either catheters (x2) missing or other spinal needles missing for a total of 4 trays missing components over past few months.Same brand, similar lots, similar reference numbers and expiration dates.

• Brand Name: ESPOCAN
• Type of Device: SPINAL EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 6995801
• MDR Text Key: 90877983
• Report Number: 6995801
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: 333192
• Device Catalogue Number: 333192
• Device Lot Number: 0061560712
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2017
• 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