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

Model Number 4433742

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  malfunction  

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.Device history record the batch history ecord was reviewed: the batch was manufactured within the specifications and no discrepancy was observed.One other similar complaint was reported on the batch 81187 released in july 2021.However, this case was not confirmed.Summary of investigation no sample was returned for investigation, however, two pictures were sent.- visual inspection of pictures: both pictures show the involved device.We can observe an access port with a catheter connected on it with a connection ring.This catheter measures around 1.5 cm.We can also observe another catheter segment which is damaged at two points: a kink and a rupture are observed at two different points.It seems to be the other part (distal part) of the catheter.However, regarding those pictures, we cannot conclude about the origin of those damages.- raw material historical review: the batch record of the catheter included into the impacted device kit was verified: batch is compliant with the defined specifications and no discrepancy was observed.Raw material used for the manufacturing of catheter was compliant at receipt too.Root cause without the complaint sample for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the incident.Conclusion without the device, the root cause could not be determined.However, the batch history record has not actually revealed failure during manufacturing process.In the future, if this incident occurs again, please retain the sample so that a complete investigation can be performed.If a sample do become available, the complaint will be reopened for further evaluation.Catheter rupture is a known complication of the access port implantation.This type of incident remains rare.No corrective action is currently envisaged.

Event Description

The child was diagnosed with leukemia and underwent implantation surgery through the right internal jugular vein infusion port at the childcare center in (b)(6).During the recent infusion process, it was found that the infusion port of the child was blocked and the catheter was broken due to obstruction.The infusion port was removed on (b)(6).The doctor removed the infusion port from the patient's body and disposed of it as medical waste.

Manufacturer Narrative

Note: product reference 4433742 is not cleared for sales in the usa, but it is similar to a product reference cleared under #510k130576.The complaint concerns 1 unit of celsite babyport set pur 4,5f iv reference 4433742 from batch 36981187.Device history record the batch record file, number 36981187 was reviewed: the batch was manufactured within the specifications and no discrepancy was observed.No other similar complaint was reported on the units from the batch released in july 2021.Summary of investigation no sample was returned for investigation; however, two pictures were sent.- visual inspection of pictures: both pictures represent the involved device.We can observe an access port with a catheter segment connected on it with a connection ring.This piece of catheter measures around 1.5 cm.We can also observe another catheter segment which seems to be the distal part of the implanted catheter.A crack is observed on this catheter segment.At the level of the crack, the wall of the catheter is deformed, its diameter is widened.This can happen when a catheter is placed under pressure.Root cause according to the incident description: "it was found that the infusion port of the child was blocked, and the catheter was broken due to obstruction" and the observed crack on the supplied pictures of the explanted device, it seems that the observed damage results of an overpressure applied inside the catheter when its distal extremity was blocked.This can happen if an injection is forced despite the blockage or after an attempt to clear the catheter blockage using a fluid under high pressure.Ifu specifies several recommendations in case of occlusion to avoid overpressure.Conclusion according to the incident description: "it was found that the infusion port of the child was blocked, and the catheter was broken due to obstruction" and the observed crack on the supplied pictures of the explanted device, it seems that the observed damage is due to wrong handling, to an overpressure applied.Also, the batch history record has not actually revealed failure during manufacturing process and no other similar complaint was reported on the impacted batch.The ifu gives recommendations to avoid such incident.This type of complication remains rare.No corrective action is currently envisaged.

• 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 Key: 18111761
• MDR Text Key: 328139360
• Report Number: 9612452-2023-00022
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 04038653917587
• UDI-Public: 4038653917587
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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 Number: 4433742
• Device Lot Number: 36981187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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