MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS CELSITE; ACCESS PORT SYSTEMS

Model Number 4433742

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2021

Event Type  malfunction  

Event Description

2 complaints for celsite baby port ref number 04433742 at (b)(6).In both cases the tubing of the babyport was found torn after 2 months from the date of transplant and had to be taken out, after being found that the product was leaking and replaced with another brand.

Manufacturer Narrative

Note: product reference 4433742 is not cleared for sales in the usa, but it is similar to the product reference cleared under #510k130576.Investigation results: we did not received the complaint sample, the batch number nor the x-ray pictures for investigation.Conclusion: without elements, 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.

Manufacturer Narrative

Batch history review: we have checked the manufacturing file of batch nr 36974927 of celsite access ports which complies with our specifications and does not present any discrepancy.The burst test performed during incoming inspection of the catheter batch is compliant with the current specification.No other similar incident has been reported to us on this batch of 149 access ports released in february 2021.Investigation results: we received for investigation one celsite babyport access port from batch 36974927, with its catheter in two parts.At 12 cm from the extremity of the catheter connected to the port, the catheter is burst.There is some dry blood inside the catheter dimensional measurements: we have measured the returned catheter in order to check its conformity to our specification.All the measurements conform to our specifications.Functional test: after having cleaned the catheter, we have performed a burst test on the distal part of the returned catheter.To perform this test and to obtain a sufficiently high pressure inside the catheter, we clamp the end of the catheter.Otherwise, it is impossible to explode the catheter.The result is within our requirements.Conclusion: the evaluation of the explanted device did not allow us to detect any manufacturing defect on the device.The catheter burst observed results from the fact that excessive pressure has been applied during the injection while the catheter was obstructed (firbrin sleeve observed by the physician).The ifu specifiy, in case of obstruction of the system, never try to clear the blockage using a fluid under high pressure which carries the risk of catheter fracture and migration.The ifu gives somme recommandation to avoid this situation.As no manufacturing defect has been detected on the returned sample and as the burst is due to a misuse of the device, no corrective action is envisaged.

Event Description

The tubing of the babyport was found torn after 2 months from the date of implantation and had to be taken out, after being found that the product was leaking and replaced with another brand.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEMS
• 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 Key: 12622099
• MDR Text Key: 281432314
• Report Number: 9612452-2021-00050
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): Y
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4433742
• Device Lot Number: 36974927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR