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

Model Number 4433734

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Anxiety (2328)

Event Date 08/08/2022

Event Type  Injury  

Manufacturer Narrative

Note: product reference 4433734 is not cleared for sales in the usa, but it is similar to the product reference cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr 36987377 which complies with our specifications and does not present any discrepancy.No other similar complaints have been reported on this batch of access ports released in february 2022.Investigation results: we received for investigation one celsite brachial access port from batch 36987377 with its catheter and connection ring.The catheter and the ring are disconnected from the port.The catheter measures 43.7 cm.No manufacturing defect is visible on the returned device.Very few puncture marks are visible on the septum.Dimensional measurements: the catheter, the exit cannula and the connection ring were measured.All measures are compliant with the specifications.Disconnection test: we have performed a disconnection test on the returned device.The disconnection force obtained is more than 3 times superior to the requirement of the iso 10555-6 standard.The characteristic conforms to the specification.X-ray picture review: we received one x-ray picture for review.The catheter is visible at the level of the patient's heart.No x-ray picture taken after implantation procedure and showing the catheter connected to the port were returned.Conclusion: no manufacturing defect has been detected on the returned sample; it conforms to our specification.It is highly suspected that the disconnection of the catheter, 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 incident ((b)(4)), no corrective action is envisaged.

Event Description

"female patient 63 years chemo through port for cancer therapy.While patient was not harmed she suffered anxiety, had to be booked in for port removal and hospital stay.Port was being used for chemo after infusion staff could not draw blood, flush use line.Staff attempted to re-access, hub felt like it had movement.Disconnected patient and they were discharged.One week later patient was referred to emi for portogram, on examination line was dislodged from hub and sitting within chest/heart.".

• 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: 15392440
• MDR Text Key: 299590859
• Report Number: 9612452-2022-00043
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4433734
• Device Lot Number: 36987377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female