Catalog Number 401622 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problems
Cerebrospinal Fluid Leakage (1772); Headache (1880)
|
Event Date 03/30/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).Investigation: a sample was not received for the purpose of our investigation.Three issues were noted in the original complaint.Photos were provided only for the failure mode related to the towel.The photo clearly shows the towel lacked a hole, our investigators determined that this is a defect with the material and should have been identified.Neither samples or photographs were provided for the purpose of our investigation in the leakage or coloration complaints.As a result the root cause for neither of these could be determined at this time.Bd will continue to track and trend for this issue.Production process survey: the batch number of the customer¿s feedback was investigated, product number : 401622, lot number: 7324049.Production date: december 2017, quantity 1.4k.Check the batch records of the batch and there is no abnormality in the production process.
|
|
Event Description
|
It was reported that the disposable towel in the bd durasafe plus¿ epidural lock cse needle set, did not have a hole as intended for a proper sterile field.It was also reported that there was cerebrospinal fluid leakage between the puncture needle and the syringe while taking the sample, this resulted in inaccurate administration, and possible headache complications after surgery.There was no report of exposure, injury or medical intervention.
|
|
Search Alerts/Recalls
|
|