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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 03/01/2019

Event Type  malfunction  

Event Description

Pt had epidural for pain control in labor, clear clamp came undone from epidural catheter and patient became painful.Anesthesia notified and replaced clamp.Device: perifix fx epidural anesthesia tray.

• Brand Name: PERIFIX FX EPIDURAL ANESETHISA TRAY
• Type of Device: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8711532
• MDR Text Key: 148416392
• Report Number: 8711532
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2019,06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10220 DA