Catalog Number 393222 |
Device Problems
Material Puncture/Hole (1504); Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/24/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the bd venflon¿ pro safety catheter cannula had small holes in it caused by the needle piercing through it during use.The following information was provided by the initial reporter: when vps is inserted into the vein.The cannula has small holes, also not fixed well.
|
|
Manufacturer Narrative
|
Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
|
|
Manufacturer Narrative
|
H6: investigation summary our quality engineer inspected the 1 photo submitted for evaluation.The reported issues of needle bent; catheter defective / damaged were not confirmed but the failure needle through catheter was observed upon inspection and testing of the samples.From the returned photo, blood was observed in the catheter and cannula hub.This indicates a successful penetration.It would not be possible to penetrate the vein if the product had the needle pierced through catheter.Therefore, the probable root cause for the reported defects could be due to user partially withdrawing the needle from the catheter and reinserting the needle into the catheter.The needle than pierced through the catheter, resulting in the damage.However, as it is not possible to confirm how the product was used, the root cause cannot be confirmed.
|
|
Event Description
|
It was reported that the bd venflon¿ pro safety catheter cannula had small holes in it caused by the needle piercing through it during use.The following information was provided by the initial reporter: when vps is inserted into the vein.The cannula has small holes, also not fixed well.
|
|
Search Alerts/Recalls
|