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

Catalog Number 555170

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 11/04/2017

Event Type  malfunction  

Event Description

A (b)(6) female undergoing epidural placement for use during labor & delivery of infant.Following placement of the b.Braun epidural catheter, the provider noted fluid beading up on the catheters near the insertion site.Upon closer inspection while injecting the test dose, the provider could see a small drop of liquid coming through a pinhole defect in the catheter at around the 12-13 cm mark.The catheter was immediately removed with the tip intact.A new catheter was placed.No complications were report with placement of the 1st or 2nd catheter.
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manufacturer response for epidural catheter, b.Braun design options perifix fx epidural anesthesia tray (per site reporter).
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the catheter was returned to the b.Braun representative.At the time to this report, no information available regarding manufacturer's response.

• Brand Name: PERIFIX FX EPIDURAL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18019
• MDR Report Key: 7182131
• MDR Text Key: 96966227
• Report Number: 7182131
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 555170
• Device Lot Number: 0061572874
• Other Device ID Number: CESK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: IT IS UNKNOWN WHETHER OTHER DEVICES WERE BEING USE; NO OTHER THERAPIES
• Patient Age: 19 YR
• Patient Weight: 69