Catalog Number 324902 |
Device Problem
Volume Accuracy Problem (1675)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/21/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that 2 bd 1ml syringes experienced scale marking issues.The following information was provided by the initial reporter: the printed calibrated markings come-off while using the syringe.
|
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 0349930.All inspections were performed per the applicable operations qc specification.There were two (2) notifications noted that did not pertain to the complaint.H3 other text : see h.10.
|
|
Event Description
|
It was reported that 2 bd 1ml syringes experienced scale marking issues.The following information was provided by the initial reporter: the printed calibrated markings come-off while using the syringe.
|
|
Search Alerts/Recalls
|