Catalog Number 261203 |
Device Problem
Device Markings/Labelling Problem (2911)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/18/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that bd bbl¿ catalase reagent dropper dates of expiration on box and bottle do not match the coc.The following information was provided by the initial reporter: reported certificate of compliance and shipment detail document with lot# b01f122m dated july 2024 but the box and droppers has lot# b01f122m dated june 2024.Spoke with cx and she verified for lot# b01f122m has date july 2024.Would you send our customer a no charge replacement with a box that has lot# b01f122m has dated july 2024.
|
|
Manufacturer Narrative
|
H6.Investigation summary: complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the dhr did not reveal any manufacturing issues.Sample analysis: an inspection of the photo did the noted defect.An inspection of the retentions was satisfactory.The erp system that generated the certificate had the wrong expiration date.Evaluations results: based on the investigation, the defect was observed on the photo and erp system.The wrong data was entered into the erp system which caused the noted discrepancy.A complaint trend is not present.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed.The expiration date was corrected in the erp system and the certificate corrected.A complaint trend on this issue is not present with this product.No further actions will be taken as this is an isolated incident.Bd will continue to monitor for trending.
|
|
Event Description
|
It was reported that bd bbl¿ catalase reagent dropper dates of expiration on box and bottle do not match the coc.The following information was provided by the initial reporter: reported certificate of compliance and shipment detail document with lot# b01f122m dated (b)(6) 2024 but the box and droppers has lot# b01f122m dated (b)(6) 2024.Spoke with cx and she verified for lot# b01f122m has date (b)(6) 2024 would you send our customer a no charge replacement with a box that has lot# b01f122m has dated (b)(6) 2024.
|
|
Search Alerts/Recalls
|