Model Number 50-7500B |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/03/2022 |
Event Type
malfunction
|
Event Description
|
Valve drips when access tip is connected.If none is connected, the valve is tight.The access tip might be the problem here.Where did leakage occurred? > valve drips when access tip is connected.If none is connected, the valve is tight.The access tip might be the problem here.Is this at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked in to the valve? > access tip.Yes fully clicked.Was there damage noted on the access tip or patient's valve.> unknown.Where is the catheter located? > chest.Is there a sample available showing the reported issue? > i have to check this.What was the impact to the patient? > no impact.
|
|
Manufacturer Narrative
|
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(4).Patient problem code: (b)(4).
|
|
Event Description
|
Valve drips when access tip is connected.If none is connected, the valve is tight.The access tip might be the problem here.Where did leakage occurred? valve drips when access tip is connected.If none is connected, the valve is tight.The access tip might be the problem here.Is this at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked in to the valve? access tip.Yes fully clicked.Was there damage noted on the access tip or patient's valve.Unknown.Where is the catheter located? chest.Is there a sample available showing the reported issue? i have to check this.What was the impact to the patient? no impact.
|
|
Manufacturer Narrative
|
Pr (b)(4) follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001394353 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer here.
|
|
Search Alerts/Recalls
|