INTERVASCULAR SAS INTERGARD WOVEN STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
|
Back to Search Results |
|
Model Number IGW0028-15 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/23/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number 23f29.Moreover, there is no other similar complaint for hole in the tyvek lid between 1-jan-2023 to 12-mar-2024.(10/213/4248) the involved device was visually inspected by the quality assurance supervisor.The visual inspection confirmed the presence of a hole on the inner tyvek lid of the involved product.It was concluded that the product is non compliant with the product specification, the sterile barrier has been broken.It should be noted that at the primary packaging stage, no thin and sharp object is present on the production line.The historical data review results were provided to the qa supervisor to determine the cause of the event.It was concluded that the most likely root cause of the incision was accidental handling of the product packaging when unpacking the prosthesis.(4315) based on the evaluation of the returned product and the investigation findings, no conclusion can be drawn of the exact origin of the defect.One hypothesis is that the incision leading to the hole may have been caused during packaging handling after the outer lid was removed at the time of unpackaging the prosthesis.
|
|
Event Description
|
It was reported to intervascular that after opening the product packaging, a pinhole was observed on the surface of the internal tyvek lid.The product was was not used and was replaced to complete the operation.
|
|
Search Alerts/Recalls
|
|
|