ST PAUL DELTEC PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYST; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS,
|
Back to Search Results |
|
Model Number 21-4155-24 |
Device Problem
Disconnection (1171)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/08/2019 |
Event Type
malfunction
|
Event Description
|
It was reported that device was installed in patient on (b)(6) 2019.On (b)(6) 2019, problems were detected after the device was punctured, detecting filtration.Chest x-ray performed.Upon removal of device, it was found that the base was not attached to the rest of the reservoir.A new device was installed.No patient injury was reported.
|
|
Manufacturer Narrative
|
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The one (1) picture was received and can be observed that the port which is inserted is detached from the housing.The sample was visually inspected at a distance of 12? to 16? under normal conditions of illumination.The insert is loose and it can remove from the housing; the septum was collocated in the right position but it does not exceeds the surface of the housing.No marks of the detached of weld were detected inside the housing nor around the inner side of the insert.The most probably root causes are lack of knowledge of the operation of the welding machine and lack of process controls in the ultrasonic machine.The operator does not detect that the port was not welded.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
|
|
Search Alerts/Recalls
|
|
|