Catalog Number 309657 |
Device Problem
Missing Information (4053)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/10/2023 |
Event Type
malfunction
|
Event Description
|
It was reported while using bd plastipak¿ 3ml syringe there were scale marking issues.There was no report of patient impact.The following information was provided by the initial reporter: we have been receiving complaints about these syringes.They are missing numbers and they are uneven.
|
|
Manufacturer Narrative
|
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
H.6.Investigation summary: two photos were provided to our quality team for investigation.Upon examination of the returned photos, it was observed that two syringes have skewed scale markings and missing half of the graduation lines towards the tip of the syringe.Potential root cause for the scale marking defect is associated with the marking process.These defects are occurring below an expected rate so no corrective actions will be made at this time.Furthermore, a device history record review was completed for provided lot number 2054353.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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 while using bd plastipak¿ 3ml syringe there were scale marking issues.There was no report of patient impact.The following information was provided by the initial reporter: we have been receiving complaints about these syringes.They are missing numbers and they are uneven.
|
|
Search Alerts/Recalls
|