Catalog Number 367344 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/26/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
D2: common device name: blood specimen collection device; intravascular administration set.D.2.Medical device type: one additional code applies jka.G5: pma/510(k)#: one additional code applies; k220212.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
|
Report 7 of 8.It was reported that while using bd vacutainer® push button blood collection set, the blood stop flowing, and clogged causing back flow into the needle.This caused leakage at the luer-lock.No report of adverse or injury to the patient or the healthcare worker.
|
|
Manufacturer Narrative
|
The following fields have been updated with corrected and/or additional information.D10: device available for evaluation: yes d10: returned to manufacturer on: 22-mar-2024 h.6.Investigation summary: material #: 367344 lot/batch #: 3317455 bd received 25 samples and 1 photo for investigation.The photo was reviewed, and it shows the product unit label, confirming the lot number.Additionally, the customer samples were evaluated by functional draw testing and the indicated failure mode for leakage with the incident lot was not observed as all product specifications were met.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 is unable to be confirmed for the indicated failure mode leakage.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
|
|
Event Description
|
Report 7 of 8 it was reported that while using bd vacutainer® push button blood collection set, the blood stop flowing, and clogged causing back flow into the needle.This caused leakage at the luer-lock.No report of adverse or injury to the patient or the healthcare worker.
|
|
Search Alerts/Recalls
|