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. CARESITE®; SET, ADMINISTRATION, INTRA
  • 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. CARESITE®; SET, ADMINISTRATION, INTRA Back to Search Results
Catalog Number 415122-01
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Arrhythmia (1721); Unspecified Infection (1930)
Event Date 09/12/2023
Event Type  Injury  
Event Description
As reported by the user facility: leaks and infections on picc line catheters, ablation and rest in the operating room for continued treatment of patients.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number: (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARESITE®
Type of Device
SET, ADMINISTRATION, INTRA
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 Key18357674
MDR Text Key330898343
Report Number2523676-2023-00857
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K140311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number415122-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
-
-