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

Model Number 4433742

Device Problems Crack (1135); Fracture (1260)

Patient Problem Extravasation (1842)

Event Type  malfunction  

Event Description

"loss of integrity/broken catheter line.".

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.Batch history review: we have checked the manufacturing file of batch nr 36953093 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported on this batch of access ports released in september 2019.Investigation results: despite requests, we did not receive the complaint sample nor x-ray pictures for evaluation.Conclusion: without the complaint sample or x-ray pictures, we cannot conclude on the real cause of this incident.However, this is an isolated incident inside the whole batch.Catheter rupture is a known complication of the access port implantation, documented in the ifu, this is a rare incident consequently, no corrective action is envisaged for the moment.

Event Description

"loss of integrity/broken catheter line.".

Manufacturer Narrative

Device history record the batch record, number 36953093 was reviewed: the batch is within the specifications and no discrepancy was observed.No other similar complaint was reported on the units released in september 2019.Summary of investigation: no x-rays pictures of the implanted device the day of implantation and the day of the defect detection were shared.No questionnaire regarding the access port incident was complete.One celsite babyport set from batch 36953093, was returned for investigation.The implantation route of the catheter is unknown.Visual inspection of the returned device: access port housing.Some blood traces were detected, and coagulated blood was inside.Around 10 puncture marks were visible inside the silicone septum.Catheter.A part of catheter of around 13.5 cm long was still connected to the access port exit cannula.Coagulated blood was present inside the catheter.2 diametrically opposite longitudinal cracks (around 7 mm and 6 mm long) were detected from around 7 cm of the exit cannula.Dimensional measures: the inner and outer diameters of the catheter were verified and are compliant with the defined specifications.Conclusion: the compliant is not confirmed.The observed longitudinal cracks result of a catheter kinked or pinched while handling or due to the choice of the implantation route.Indeed, in case of an implantation via the sub-clavian route, the catheter can be crushed in the costo-clavicular space and repeated squeezing led to cracks of the catheter: it is the pinch-off syndrome.Indeed, the observed cracks seem to be due to the implantation catheter trajectory (pinched, kinked or strongly angled).The x-ray pictures could allow to confirm this hypothesis.It is a rare incident.No actions plan is foreseen at that time.

Manufacturer Narrative

Device history record the batch record, number 36953093 was reviewed: the batch is within the specifications and no discrepancy was observed.No other similar complaint was reported on the units released in september 2019.Summary of investigation no x-rays pictures of the implanted device the day of implantation and the day of the defect detection were shared.No questionnaire regarding the access port incident was complete.One celsite babyport set from batch 36953093, was returned for investigation.The implantation route of the catheter is unknown.Visual inspection of the returned device: access port housing.Some blood traces were detected, and coagulated blood was inside.Around 10 puncture marks were visible inside the silicone septum.Catheter.A part of catheter of around 13.5 cm long was still connected to the access port exit cannula.Coagulated blood was present inside the catheter.2 diametrically opposite longitudinal cracks (around 7 mm and 6 mm long) were detected from around 7 cm of the exit cannula.Dimensional measures: the inner and outer diameters of the catheter were verified and are compliant with the defined specifications.Conclusion the compliant is not confirmed.The observed longitudinal cracks result of a catheter kinked or pinched while handling or due to the choice of the implantation route.Indeed, in case of an implantation via the sub-clavian route, the catheter can be crushed in the costo-clavicular space and repeated squeezing led to cracks of the catheter: it is the pinch-off syndrome.The ifu gives recommendations to avoid such event.It is a rare incident.No actions plan is foreseen at that time.

Event Description

"loss of integrity/broken catheter line.".

• 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: 16972204
• MDR Text Key: 315932824
• Report Number: 9612452-2023-00009
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2023

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 Model Number: 4433742
• Device Lot Number: 36953093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 04/17/2023; 04/17/2023
• Supplement Dates FDA Received: 07/24/2023; 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1