MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX; ANESTHESIA CONDUCTION KIT

Model Number EC20C

Device Problem Device Or Device Fragments Location Unknown (2590)

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

Event Date 07/19/2015

Event Type  malfunction  

Event Description

During epidural replacement for a patient in labor, an anesthesia physician placed the epidural and was in the process of withdrawing the catheter to achieve 12 cm at the skin level when he pulled out a sheared portion of catheter.No catheter was at the skin puncture site.A sterile dressing was placed over epidural site and an a ct scan was performed.No catheter fragment is visible via images.The packaging was not saved therefore we do not know the lot number.Manufacturer response for epidural catheter, 20 gauge closed tip periflex epidural catheter (per site reporter): have asked manufacturer to share finding with us when their evaluation is completed.

• Brand Name: PERIFIX
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 5035609
• MDR Text Key: 24307462
• Report Number: 5035609
• 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: Patient
• Report Date: 07/22/2015,07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: EC20C
• Device Catalogue Number: 333540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR