Catalog Number 368969 |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/16/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer 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.
|
|
Event Description
|
It has been reported that the bd vacutainer® sst¿ ii advance plus blood collection tube has been found experiencing tube push off during use.The following has been provided by the initial reporter: the ivf ward complained that the tubes are jumping out of the holder while taking the blood.The nurse who draws the blood said that she needs to hold the tube firmly in order to keep it inside the holder while drawing blood.
|
|
Event Description
|
It has been reported that the bd vacutainer® sst¿ ii advance plus blood collection tube has been found experiencing tube push off during use.The following has been provided by the initial reporter: the ivf ward complained that the tubes are jumping out of the holder while taking the blood.The nurse who draws the blood said that she needs to hold the tube firmly in order to keep it inside the holder while drawing blood.
|
|
Manufacturer Narrative
|
Investigation summary bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for stopper pullout with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for testing and upon completion, no issues were observed relating to stopper pullout as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.
|
|
Search Alerts/Recalls
|