BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
|
Back to Search Results |
|
Model Number 367957 |
Device Problem
Unclear Information (4052)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/07/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation summary: bd had not received samples, but three (3) photos were provided for investigation.The photos were reviewed and the indicated failure mode for tubes attached to shelf pack label was observed.Additionally, two (2) retained shelf packs from bd inventory were evaluated by visual examination and the issue of tubes attached to shelf pack label was not observed.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.This complaint has been confirmed for the indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
|
|
Event Description
|
It was reported by the customer that on bd vacutainer® sst¿ ii advance plus blood collection tubes the plastic film and the test tube label were stuck together, resulting in damage to the label outside the test tube when taking it.This occurred 4 times.Verbatim: when customer used the 367957 process, there was no problem with the plastic film of the outer packaging of 367957, but the plastic film and the test tube label were stuck together, resulting in damage to the label outside the test tube when taking it.The label on the outside of the test tube is an important reference and basis for the use of this product.In this case, the test tube cannot be used.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-07-17.H.6.Investigation summary: bd received six (6) samples and three (3) photos for investigation.The photos were reviewed and the indicated failure mode for tubes attached to shelf pack label was observed.Evaluation of the samples indicated 2 tubes stuck to the shelf pack label and 4 tubes with damaged unit labels.Additionally, two (2) retained shelf packs from bd inventory were evaluated by visual examination and the issue of tubes attached to shelf pack label was not observed.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.This complaint has been confirmed for the indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.
|
|
Event Description
|
It was reported by the customer that on bd vacutainer® sst¿ ii advance plus blood collection tubes the plastic film and the test tube label were stuck together, resulting in damage to the label outside the test tube when taking it.This occurred 4 times.Verbatim: when customer used the 367957 process, there was no problem with the plastic film of the outer packaging of 367957, but the plastic film and the test tube label were stuck together, resulting in damage to the label outside the test tube when taking it.The label on the outside of the test tube is an important reference and basis for the use of this product.In this case, the test tube cannot be used.
|
|
Search Alerts/Recalls
|
|
|