Model Number 22003E-07 |
Device Problems
Complete Blockage (1094); Restricted Flow rate (1248)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/24/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that the bd alaris¿ smartsite¿ extension set would not flush through the ss due to flow issues/occlusion.The following information was provided by the initial reporter: "inability to flush through ss.".
|
|
Event Description
|
It was reported that the bd alaris¿ smartsite¿ extension set would not flush through the ss due to flow issues/occlusion.The following information was provided by the initial reporter: "inability to flush through ss".
|
|
Manufacturer Narrative
|
H6: investigation summary: no product or photo was returned by the customer.It was reported that the product would not flush.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 22003e-07 because an invalid lot number was provided by the customer.A definitive root cause for the customer's experience could not be determined as no needle-free connector (smartsite) was returned.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion of this nature.Capa 1998036 has been initiated.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston during the assembly process.Fluorosilicone is a lubricant used to ensure proper functioning of the needle-free connector when activated.
|
|
Search Alerts/Recalls
|