Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX; EPIDURAL ANESTHESIA KIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN MEDICAL INC. PERIFIX; EPIDURAL ANESTHESIA KIT Back to Search Results
Model Number 332220
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes Pain (1994); Disability (2371); Foreign Body In Patient (2687)
Date of Event 04/19/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Without the actual device and/or lot number, a thorough investigation could not be performed.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 or Problem Description
As reported by the user facility: it was reported that when the crna (certified registered nurse anesthetists) attempted to start the epidural and was unsuccessful.When the nurse tried again to start the epidural, the nurse stated that a four (4) inch segment of the catheter broke off into the patient's third lumbar vertebra epidural space.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERIFIX
Common Device Name
EPIDURAL ANESTHESIA KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown, pa
MDR Report Key9935630
Report Number2523676-2020-00103
Device Sequence Number2732219
Product Code OGE
UDI-Device Identifier04046964178320
UDI-Public04046964178320
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number332220
Device Catalogue Number332220
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/20/2020
Initial Report FDA Received Date04/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-