|
Catalog Number 405075 |
Device Problem
Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/21/2021 |
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 4 bd univia¿ whitacre spinal needles would not thread through their introducer needles and got stuck in them.The following information was provided by the initial reporter: "the anesthesiologist reported.That the spinal needle whitacre 27g x 3.5 ref 405075 lot 2009019 does not comply with the technical characteristics required, because in several samples the needle does not slide through the introducer but it sticks in it, and as a result there is friction between the metals of the needle and the introducer.They claim that except the inability to enter the subarachnoid space, there might be metal shavings that could cause meningitis." the incident includes a report to national drug organization about failure in the use of the reported spinal needle.Samples will be collected next week and will be sent to you asap.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-01-10.H6: investigation summary: two samples received for investigation.Upon visual inspection at 10x magnification, no defect of incorrect assembly was observed.The hub of the needle and the flaring of the cannula where it engages with the molded hub is correct.No crushing can be seen at this point, which is where gripping can occur.The needle is removed from the introducer and reassembled to detect the grip or friction mentioned by the customer.The samples were inspected (magnifying glass and microscope used) and no defects were found.A device history review was performed for the reported lot 2009019 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.The stylets were inserted through the introducers, no friction was noted during connection and the needle could smoothly advance without issue in all samples evaluated.The internal diameter of the introducers was measures and found to be within specification.Product undergoes a series of testing and inspections throughout the manufacturing process to ensure the quality and functionality of the device.All lot release testing was reviewed and found product met requirements, no issues were identified.Based on the quality team's investigation, a root cause related to our manufacturing process cannot be identified at this time.
|
|
Event Description
|
It was reported that 4 bd univia¿ whitacre spinal needles would not thread through their introducer needles and got stuck in them.The following information was provided by the initial reporter: "the anesthesiologist reported.That the spinal needle whitacre 27g x 3.5 ref 405075 lot 2009019 does not comply with the technical characteristics required, because in several samples the needle does not slide through the introducer but it sticks in it, and as a result there is friction between the metals of the needle and the introducer.They claim that except the inability to enter the subarachnoid space, there might be metal shavings that could cause meningitis." the incident includes a report to national drug organization about failure in the use of the reported spinal needle.Samples will be collected next week and will be sent to you asap.
|
|
Search Alerts/Recalls
|
|
|