Model Number 405671 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/04/2021 |
Event Type
malfunction
|
Event Description
|
It was reported when using the bd luer-lok, bd glaspak, the device experienced the depth markings missing (inappropriate graduation markings).The following information was provided by the initial reporter.The customer stated: it was reported the marking isn't working.The markings not working when using spinals.I had another one today did the same thing spinal did not set up marcain not working so now i have had 3 in a week.Lot number for all 3 so far has been.
|
|
Manufacturer Narrative
|
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported when using the bd luer-lok, bd glaspak, the device experienced the depth markings missing (inappropriate graduation markings).The following information was provided by the initial reporter.The customer stated: it was reported the marking isn't working.The markings not working when using spinals.I had another one today did the same thing spinal did not set up marcain not working so now i have had 3 in a week.Lot number for all 3 so far has been.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/18/2022.H.6.Investigation: one sample was provided to our quality team for investigation.The anesthetic ampule and contents were examined.No discernible haze or particulate matter was observed, and the returned sample appeared clear.The sample appeared colorless and did not contain any coloration or hue and had the appearance of water.The returned sample met the criteria for passing therefore, the reported failure mode was confirmed.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h.10.
|
|
Search Alerts/Recalls
|