Catalog Number 305209 |
Device Problem
Missing Information (4053)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/27/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the bd oral syringe label content was missing.The following information was provided from the initial reporter: "expiry date not mentioned on bag.".
|
|
Manufacturer Narrative
|
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
(b)(4) ¿ follow up mdr for device evaluation.No samples or photos received by our quality team for evaluation.Though please note that this product does not have an expiration date.The reported defect is not a true defect and is a design-related inquiry.Batch 0148085 is considered in compliance with our product specification requirements.We appreciate you taking the time to bring this observation to our attention.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.H3 other text : see h10 manufacture narrative.
|
|
Event Description
|
No additional information.
|
|
Search Alerts/Recalls
|