BECTON DICKINSON, S.A. BD® QUINCKE SPINAL NEEDLE 27GA 3.50 IN; ANESTHESIA CONDUCTION NEEDLE
|
Back to Search Results |
|
Catalog Number 405259 |
Device Problem
Difficult to Open or Remove Packaging Material (2922)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/20/2022 |
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 bd® quincke spinal needle 27ga 3.50 in had poor perforation on the packaging.The following information was provided by the initial reporter: "problem of opening the medical device: packaging glued on all sides, absence of "easy" opening to maintain good sterility practices.Current state of the patient: impossible to open the device in optimal conditions of use, risk of desterilizing the medical device since the packaging must be torn to be able to take out the needle.Actions taken in the health care institution for the management of the patient: nr.¿.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 24oct2022.H6: investigation summary: one box with fifteen units were provided to our quality team for investigation.After visual inspection, it was observed that the peel tab of the package was sealed, preventing proper opening of the package.A device history review was performed for reported lot 2203003, finding a mechanical intervention related to the transversal blade and cutting valve.An incident was detected due to an error in the packaging machine causing the cross cutting blades to move and cut in the incorrect location, resulting in the peel tab remaining sealed as seen in the products returned.After a mechanical intervention is completed, inspections are performed before the equipment can restart.All records established the inspections were completed appropriately.Packaging parameters are set and validated according to procedure.Product undergoes testing and inspections throughout manufacturing, all results were reviewed for lot 2203003 and verified machine and packaging parameters were within required limits.Based on our investigation, this incident was determined to be related to issue with the cutters that occurred during manufacturing and the machine operator not properly discarding the impacted products.Manufacturing personnel have been notified of this incident to increase awareness.Complaints received on this device and the reported condition will continue to be tracked and trended for future occurrences.
|
|
Event Description
|
It was reported bd® quincke spinal needle 27ga 3.50 in had poor perforation on the packaging.The following information was provided by the initial reporter: "problem of opening the medical device: packaging glued on all sides, absence of "easy" opening to maintain good sterility practices.Current state of the patient: impossible to open the device in optimal conditions of use, risk of desterilizing the medical device since the packaging must be torn to be able to take out the needle.Actions taken in the health care institution for the management of the patient: nr¿.
|
|
Search Alerts/Recalls
|
|
|