Catalog Number 394600 |
Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2023 |
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 connecta¿ stopcock disconnected from the ebus bronchoscope when trying to tighten it.The following information was provided by the initial reporter: "they attach the connecta to a ebus bronchoscope (olympus bf-uc190f and bf-uc180f) and even when trying to tighten the connecta extra tight they experience that the connecta disconnects unintentionally.It happens 50% of the times they use it.They never had any issues with the stopcock they used before (unknown brand).No harm to patient or staff.".
|
|
Event Description
|
It was reported that the bd connecta¿ stopcock disconnected from the ebus bronchoscope when trying to tighten it.The following information was provided by the initial reporter: "they attach the connecta to a ebus bronchoscope (olympus bf-uc190f and bf-uc180f) and even when trying to tighten the connecta extra tight they experience that the connecta disconnects unintentionally.It happens 50% of the times they use it.They never had any issues with the stopcock they used before (unknown brand).No harm to patient or staff.".
|
|
Manufacturer Narrative
|
H6: investigation summary: it was reported the connecta disconnects from an ebus bronchoscope.To aid in the investigation, photos were provided for evaluation by our quality team.In the photos, no problems are observed with the device.As the lot provided is 'unknown,' a device history record review could not be completed.Based on the investigation, bd was not able to confirm the customer¿s indicated failure mode.
|
|
Search Alerts/Recalls
|