Model Number 364958 |
Device Problem
Overfill (2404)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/02/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube there was overfill.The following information was provided by the initial reporter: translated to english.The customer stated: "tubes are filled completely which lead to problems from a technical point of view.".
|
|
Event Description
|
It was reported when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube there was overfill.The following information was provided by the initial reporter: translated to english.The customer stated: "tubes are filled completely which lead to problems from a technical point of view.".
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-03-15.H6: investigation summary.Bd received twenty-one (21) samples and two (2) photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for overfill with the incident lot was not observed.Additionally, the customer samples were evaluated by functional testing and the indicated failure mode for overfill with the incident lot was not observed as all product specifications were met.Per specification for this product, there is only a minimum fill line.There is no maximum fill line required.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.
|
|
Search Alerts/Recalls
|