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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS CELSITE; ACCESS PORT SYSTEM
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B.BRAUN MEDICAL SAS CELSITE; ACCESS PORT SYSTEM Back to Search Results
Model Number 4433742
Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Patient Problems Implant Pain (4561); Swelling/ Edema (4577)
Event Type  malfunction  
Event Description
"two weeks after the infusion port was set in the patient, there was swelling around the bag during the infusion process, there was wave motion when touching, and it was suspected that there was extravasation of liquid medicine.The infusion was stopped immediately, and the catheter was found to be damaged by angiography.The infusion port was taken out the next day.Resettled on the next day.The patient's skin was swollen and painful, and the symptoms were relieved by timely intervention.At the same time, underwent two port implantation operations.".
 
Manufacturer Narrative
Note: product reference (b)(4) is not cleared for sales in the usa, but it is similar to a product reference cleared under #510k130576.The investigation onto this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
 
Manufacturer Narrative
Batch history review: we have checked the manufacturing file of batch nr 36980773 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of access ports released in july 2021.Investigation results: we did not receive the complaint sample for investigation.We received for investigation 1 picture of the explanted device.Review of the pictures of the explanted catheter: the picture shows the access port with the connection ring, as well as the catheter disconnected from the port.No defect is detectable on this picture.Conclusion: the elements we have collected to investigate this complaint file are insufficient to determined the exact device malfunction and the root cause of the reported event.This is a rare incident, no corrective action is envisaged.
 
Event Description
"two weeks after the infusion port was set in the patient, there was swelling around the bag during the infusion process, there was wave motion when touching, and it was suspected that there was extravasation of liquid medicine.The infusion was stopped immediately, and the catheter was found to be damaged by angiography.The infusion port was taken out the next day.Resettled on the next day.The patient's skin was swollen and painful, and the symptoms were relieved by timely intervention.At the same time, underwent two port implantation operations.".
 
Manufacturer Narrative
Batch history review: we have checked the manufacturing file of batch nr 36980773 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of access ports released in july 2021.Investigation results: we have received the involved device.The access port was sent with its connection ring and its catheter cut into two pieces.The proximal part measuring 1,5 cm is still connected to the port.The distal past of the catheter measures 13,9cm.No defect is visible on the device.Only 3 puncture marks are visible in the silicone membrane.The rupture facies between the proximal and the distal part of the catheter is clear cut.Its is shiny and show strias, linear marks done by a sharp object.Dimensional measurmenst: the returned device was measures.All the measures are complaint with the specifications.Fuctional test: an injection test was performed: - first, throught the access port and the proximal part of the catheter.- then, throught the access port and the distal part of the catheter.No leak or abnormality was noticed.The device functions normally.Conclusion: the elements we have collected show no manufacturing device.We have noticed a cut done by a sharp object but we cannot defined whan this cut was done (during implantation procédure or during explantation procedure).We cannot conclude on the exact root cause of the leakage observed.However this is no device related because no defect was detected on the returned device.No corrective action is envisaged.
 
Event Description
"two weeks after the infusion port was set in the patient, there was swelling around the bag during the infusion process, there was wave motion when touching, and it was suspected that there was extravasation of liquid medicine.The infusion was stopped immediately, and the catheter was found to be damaged by angiography.The infusion port was taken out the next day.Resettled on the next day.The patient's skin was swollen and painful, and the symptoms were relieved by timely intervention.At the same time, underwent two port implantation operations.".
 
Manufacturer Narrative
Batch history review: we have checked the manufacturing file of batch nr36977974 which complies with our specifications and does not present any discrepancy.No other similar complaint was reported to us on this batch of access ports released in april 2021.Investigation results: we did not receive the complaint sample for investigation.Pictures review: we received 2 pictures for review.One picture is too dark to be conclusive.On the 2nd picture received, we can see a piece of catheter.It is too short to be the complete catheter implanted on the patient.It is contaminated by blood.The graduations are not visible on it.The catheter extremities facies are not visible on this picture.X-ray picture review: we received 1 x-ray picture.On this picture, we can see a piece of catheter located just after the subclavian pinch.This is the distal part of the catheter.The length seems to correspond to the catheter presents on the photograph.The access port housing and the proximal part of the catheter have probably already been removed as they are not visible on this image.Conclusion: the x-ray pictures show that the catheter rupture occurred in the subclavian area, this allows us to hypothesis that the catheter was crushed in the costo-clavicular space and repeated squeezing have led to catheter rupture: it is the pinch-off syndrome.However, only the examination of the explanted catheter could allow us to confirm this hypothesis.The instructions for use warn the physicians against the risk entailed by placing via the subclavian route and give advice to avoid pinch-off syndrome rupture.The incident is not imputable to the device.No corrective action is envisaged.
 
Event Description
"two weeks after the infusion port was set in the patient, there was swelling around the bag during the infusion process, there was wave motion when touching, and it was suspected that there was extravasation of liquid medicine.The infusion was stopped immediately, and the catheter was found to be damaged by angiography.The infusion port was taken out the next day.Resettled on the next day.The patient's skin was swollen and painful, and the symptoms were relieved by timely intervention.At the same time, underwent two port implantation operations.".
 
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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 Key15215912
MDR Text Key297763568
Report Number9612452-2022-00038
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 12/19/2022
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
Device Operator Health Professional
Device Model Number4433742
Device Lot Number36980773
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/15/2022
Initial Date FDA Received08/12/2022
Supplement Dates Manufacturer Received07/15/2022
07/15/2022
07/15/2022
Supplement Dates FDA Received09/21/2022
12/09/2022
12/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2021
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) Required Intervention;
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