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

Model Number CE17TKFCS

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/13/2016

Event Type  malfunction  

Event Description

Anesthesiologist called to labor and delivery for the placement of an epidural catheter.After threading the epidural catheter into the patient, the anesthesiologist was unable to administer any medicine, the catheter lumen and distal ports were not patent.The epidural catheter was removed, and the md provider opened a second epidural kit (with presumably the same lot #), and discovered the second catheter had the same defect.The md provider accessed a third kit with presumably a different lot # from the anesthesia supplies cabinet in labor and delivery, and this time was able to re-access the patient's epidural space and administered epidural medicine with good effect and without further issues.All epidural catheter kits with the same lot # as the defective non patent kits, were removed and sequestered pending manufacturer notification.Manufacturer response for epidural catheter, perifix fx continuous epidural anesthesia tray with perifix 1 ga x 3-1/2 in (9cm) tuohy epidural needle winged and springwound epidural catheter 19 ga closed tip (per site reporter): not known.

• Brand Name: PERIFIX FX
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B.BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6188567
• MDR Text Key: 62824842
• Report Number: 6188567
• 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
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: CE17TKFCS
• Device Catalogue Number: 332097
• Device Lot Number: 0061519932
• Other Device ID Number: PERIFIX FX CONTINUOUS EPIDURA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 25 YR