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

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No samples were returned for evaluation in connection with this incident.Without the actual device, item number, or lot number, a thorough investigation could not be performed.A review of the discrepancy management system (dsms) database was unable to be performed as the lot number was not provided.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

Event Description

As reported via the medsun report: the certified registered nurse anesthesiologist (crna) met resistance when attempting to thread the epidural catheter.The crna attempted to pull the epidural catheter out of the needle and noticed the end of the catheter was broken off.The needle was removed and the tip of the catheter was stuck in the epidural needle.No patient injury.

• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 7946561
• MDR Text Key: 125320570
• Report Number: 2523676-2018-00082
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1