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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. PERIFIX® ANESTHESIA CONDUCTION KIT Back to Search Results
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.
 
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Brand NamePERIFIX®
Type of DeviceANESTHESIA 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 Key7946564
MDR Text Key123059769
Report Number2523676-2018-00081
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
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 Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/09/2018 Patient Sequence Number: 1
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