Catalog Number 405180 |
Device Problem
Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/29/2023 |
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 that the bd¿ quincke spinal needle experienced mixed product type in packaging.The following information was provided by the initial reporter: the customer reported that they received a box of bd spinal needles #405180 lot # 2334994 without a different size tip than the 25g they ordered and listed on the packaging.Customer opened spinal needle 405180 and the needle had a different tip other than the 25gx3.5 as the packaging indicated.
|
|
Event Description
|
It was reported that the bd¿ quincke spinal needle experienced mixed product type in packaging.The following information was provided by the initial reporter: the customer reported that they received a box of bd spinal needles #405180 lot # 2334994 without a different size tip than the 25g they ordered and listed on the packaging.Customer opened spinal needle 405180 and the needle had a different tip other than the 25gx3.5 as the packaging indicated.
|
|
Manufacturer Narrative
|
H6: investigation summary: one photo received by our quality team for investigation.Upon visual evaluation, two needles are seen; in one of the needles is observed the stylet is longer than the needle, therefore the stylet is protruding.A device history review was performed for reported lot 2334994, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the teams investigation, possible root cause is associated with stylet out of alignment which orients the length and rotation of the cannula /stylet.
|
|
Search Alerts/Recalls
|