Catalog Number 367812 |
Device Problem
Defective Component (2292)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/18/2022 |
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® serum blood collection tubes, the device experienced stopper creep out or loose closure.This event occurred 3000 times.The following information was provided by the initial reporter.The customer stated: phlebotomist observed the tube hemoguard cap was not fit properly.
|
|
Event Description
|
It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced stopper creep out or loose closure.This event occurred (b)(4) times.The following information was provided by the initial reporter.The customer stated: phlebotomist observed the tube hemoguard cap was not fit properly additional information received: 05-sep-2022 - received an email: the customer observed the issue while using the same batch approx.(b)(4) devices.Same batch stocks returned by customer is (b)(4) units.
|
|
Manufacturer Narrative
|
The following fields have been updated with additional information: b.5.Describe event or problem: it was reported when using the bd vacutainer® serum blood collection tubes, the device experienced stopper creep out or loose closure.This event occurred (b)(4) times.The following information was provided by the initial reporter.The customer stated: phlebotomist observed the tube hemoguard cap was not fit properly additional information received: 05-sep-2022 - received an email: the customer observed the issue while using the same batch approx.(b)(4) devices.Same batch stocks returned by customer is (b)(4) units.D9: device available for evaluation: yes d9: returned to manufacturer on: 2022-09-13 h.6.Investigation summary: bd received 5 samples for investigation.The samples were evaluated by functional testing and the indicated failure mode for stopper creepout with the incident lot was 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 stopper creepout.Bd has initiated further root cause investigation relating to the issue of stopper creepout through corrective and preventive actions.H3 other text : see h.10.
|
|
Search Alerts/Recalls
|