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

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(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: during placement of the epidural catheter, the anesthesiologist reported the catheter felt "funny".The anesthesiologist decided to remove the catheter and noticed the ends of the catheter were frayed upon removal.Fragments may have been retained in the patient.Limited information provided.

• Brand Name: PERIFIX®
• 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: 7946564
• MDR Text Key: 123059769
• Report Number: 2523676-2018-00081
• 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 an Adverse Event Report?: Yes
• 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
• Patient Outcome(s): Other