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

Model Number 332220

Device Problem Disconnection (1171)

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

Event Date 04/02/2019

Event Type  malfunction  

Event Description

Pt's epidural catheter was found to have come apart from the tubing at the connector.The junction had been previously taped as a workaround.The epidural had to be removed and pain was managed by the primary service.Fda safety report id# (b)(4).

• Brand Name: CONT. EPIDURAL ANESTHESIA TRAY
• Type of Device: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC. ; bethlehem PA 18018
• MDR Report Key: 8491657
• MDR Text Key: 141319036
• Report Number: MW5085631
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/03/2019

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: Health Professional
• Device Model Number: 332220
• Device Catalogue Number: GTIN 04046964178313
• Device Lot Number: 0061628279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR