Model Number 409442 |
Device Problem
Complete Blockage (1094)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/27/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, or lot number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
|
|
Event Description
|
It was reported needle sp s/su 25ga 4-11/16in whitacre had a blocked needle.The following information was provided by the initial reporter, translated from (b)(6): "at the time of starting the blockage, the medical and nursing staff noticed the bad state of the needle, so they proceeded to make the change.".
|
|
Manufacturer Narrative
|
The following field was updated due to corrected information: g.5.Is combination product?: no.H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.The complaint could not be confirmed and the root cause is undetermined.
|
|
Event Description
|
It was reported needle sp s/su 25ga 4-11/16in whitacre had a blocked needle.The following information was provided by the initial reporter, translated from spanish: "at the time of starting the blockage, the medical and nursing staff noticed the bad state of the needle, so they proceeded to make the change.".
|
|
Search Alerts/Recalls
|