Catalog Number 324910 |
Device Problems
Product Quality Problem (1506); Device Markings/Labelling Problem (2911)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/12/2018 |
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.
|
|
Event Description
|
It was reported that before use a bd insulin syringe with bd ultra-fine¿ needle was found with volumetric inaccuracy as ¿3 syringes were found with smudged scale markings and looked double imaged.There was no report of exposure, injury or medical intervention needed.
|
|
Manufacturer Narrative
|
Investigation summary: 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# 7009723.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200680290, 200680277] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 2nd related complaint for scale print distorted on lot # 7009723.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.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.If samples are received in the future the complaint will be reopened for further investigation.
|
|
Search Alerts/Recalls
|