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

Model Number 4430433

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); Swelling/ Edema (4577)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

Note: product reference (b)(4) not cleared for sales in the usa, but its catheter is similar to the product reference (b)(4) cleared under #510k130576.Batch history review: the manufacturing file was reviewed.It is compliant with our specifications and no abnormality was detected.A similar complaint has been reported by the same end customer on this batch of access ports sold since april 2020 (#9612452-2020-0029).Investigation results: we did not receive the involved sample nor x-ray pictures taken after implantation to be able to perform a thorough investigation.However, we have performed a tensile strength test a celsite access port from the same batch number.The disconnection force obtained is more than 3 times superior to the requirement of the iso 10555-6.This result conforms to our specifications.Conclusion: the disconnection test results performed on a retention sample from the same batch are compliant with our specifications.The incident was discovered less than 2 weeks after device implantation.These elements allow us to deduce that the catheter disconnection was probably due to incorrect catheter connection to the port during the implantation procedure by the physician.This is a known risk of the implantation of the access port.The complaint rate is low.The ifu's specify how to connect the catheter to the accessport to avoid this type of incident and explain the risks of incorrect connection.No corrective action is envisaged.B braun sas has provided all the information currently available to us.In spite of all reasonable efforts being made to obtain further information or the device, at this time we have not met with success.

Event Description

Patient (b)(6): port placed on (b)(6) 2020.Separation between the catheter and the access port detected at the beginning of (b)(6).

Manufacturer Narrative

Batch history review: we have checked the manufacturing file of batch nr36961854 which complies with our specifications and does not present any discrepancy.Another similar complaint (9612452-2020-0030) from the same end customer has been reported to us on this batch of (b)(4) released in april 2020.Investigation results: we did not received the sample involved in the complaint for investigation.We received for investigation 2 unused celsite st301f access port kits from batch nr 36961854.The 2 unused kits do not present any discrepancy.Dimensional measures: we have measured the returned devices in order to check their conformity to our specifications.All the characteristics conform to our specifications.Functional tests: we have performed a disconnection test on the returned samples.The disconnection force obtained are more than 3 times superior to the requirement of the iso 10555-6.These conform to our specifications.X-ray pictures examination: we received 2 x-ray pictures for review: x-ray picture 1, taken on (b)(6) 2020, the day the access port was implanted.The catheter is visible in the right jugular vein, but the contrast of the image do not allow us to see the catheter connection to the access port.X-ray picture 2, taken on (b)(6) 2020, when the disconnection was detected.On this picture, we can see that the catheter is disconnected and has migrated to the patient's heart.Conclusion: no manufacturing defect has been detected on the returned samples; they conform to our specifications.It is highly suspected that the premature disconnection of the catheter (16 days after its implantation) results from an incorrect connection of the catheter and connection ring to the access port housing during its implantation.The ifu specifies to "slide the connection ring over the catheter, firmly push the catheter onto the exit cannula ensuring the catheter covers the length of the exit cannula, slide the connection ring over the catheter and exit cannula.The connection ring should be in contact with the port"(ifu §vi-1-1-h).(b)(4).No corrective action is envisaged.

Event Description

During the 1st chemo session (patient (b)(6)), through the port placed on (b)(6) 2020, when the needle is inserted and nacl 0.9% injected (approximately 2 ml) swelling under the skin located around access port area.Aspiration to ensure blood return: no return.Needle removed.New test with a 2nd nurse: same result.Consequences: chemo performed in peripheral.Patient sent to radiography which determined the separation between the catheter and the port.The access port will be removed later.

Manufacturer Narrative

Batch history review: we have checked the manufacturing file of batch nr36961854 which complies with our specifications and does not present any discrepancy.Another similar complaint (b)(4) from the same end customer has been reported to us on this batch of 296 units released in april 2020.Investigation results: we received for investigation the "f" type catheter involved in the complaint, cut into two pieces by a sharp object.The distal part is 9 cm long; it is yellowish.The proximal part is 19 cm long.Dimensional measures: we have measured the returned catheter in order to check their conformity to our specification.All the characteristics conform to our specification.Functional tests: we have performed a disconnection test on the returned catheter and an access port housing from the same batch of our stock.The disconnection force obtained is more than 3 times superior to the requirement of the iso 10555-6.Conclusion: no manufacturing defect has been detected on the used and unused samples.It is highly suspected that the premature disconnection of the catheter (only 16 days after its implantation) results from an incorrect connection of the catheter and connection ring to the access port housing during its implantation.The ifu specifies to "slide the connection ring over the catheter, firmly push the catheter onto the exit cannula ensuring the catheter covers the length of the exit cannula, slide the connection ring over the catheter and exit cannula.The connection ring should be in contact with the port"(ifu §vi-1-1-h) this is a rare occurrence (0.008%).No corrective action is 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
• MDR Report Key: 10343132
• MDR Text Key: 202090395
• Report Number: 9612452-2020-00030
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4430433
• Device Lot Number: 36961854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR