MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY; EPIDURAL ANESTHESIA KIT

Model Number CE17TKFC

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 06/12/2014

Event Type  malfunction  

Event Description

The plunger was stuck on a glass syringe from an epidural anesthesia tray.The plunger would not draw up because it was jammed or stuck inside the barrel.A scrub tech worked with the syringe and was able to get the plunger loose.A tiny piece of paper is believed to have been between the plunger and the barrel which prevented the plunger from moving.Two glass syringes have been found so far.Only one syringe was provided as a sample; unfortunately, it is no longer stuck because the scrub tech got it unstuck.

• Brand Name: PERFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 3908527
• MDR Text Key: 19803245
• Report Number: 3908527
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/13/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: CE17TKFC
• Device Catalogue Number: 332079
• Device Lot Number: 61355722
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1