• 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 SAS CELSITE; ACCESS PORT SYSTEM

  • 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 SAS CELSITE; ACCESS PORT SYSTEM Back to Search Results
Model Number 4430433
Device Problem Fracture (1260)
Patient Problem Burning Sensation (2146)
Event Date 05/31/2021
Event Type  Injury  
Manufacturer Narrative
Note: product reference (b)(4) is not cleared for sales in the usa, but its catheter is similar to the product reference cleared under #510k130576.Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy.A similar complaint has been reported to us by the same hospital on this batch of access ports released in (b)(6) 2020.Investigation results: we did not received the complaint sample nor the x-ray pictures for investigation.The picture recieved shows a catheter rupture under the connection ring.Conclusion: without the complaint sample or the x-ray pictures for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the incident.If new element become available in the future, we will re-open this complaint.Catheter rupture is a known complication of the access port implantation that could have different root causes.This is a rare incident.No corrective action is currently envisaged.
 
Event Description
"b.Braun catheter ruptured after use in chemotherapy.The catheter was inserted after diagnosis.In the chemotherapy, the patient felt a burning sensation, and the catheter was removed via hemodynamics, and replaced another catheter with the same brand.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CELSITE
Type of Device
ACCESS PORT SYSTEM
Manufacturer (Section D)
B.BRAUN MEDICAL SAS
26 rue armengaud
saint cloud, 92210
FR  92210
Manufacturer (Section G)
B.BRAUN MEDICAL SAS FRANCE
30 avenue des temps modernes
chasseneuil du poitou 86360
FR   86360
Manufacturer Contact
catherine boismenu
30 avenue des temps modernes
chasseneuil du poitou, 86360
FR   86360
MDR Report Key12412174
MDR Text Key269527450
Report Number9612452-2021-00044
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4430433
Device Lot Number36970992
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age32 YR
-
-