Catalog Number 383318 |
Device Problems
Detachment Of Device Component (1104); Fail-Safe Problem (2936)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/20/2017 |
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.(b)(6).(b)(4).
|
|
Event Description
|
It was reported that during use, the staff member was inserting the 24 g x 0.75 in.Bd saf-t-intima¿ iv into the patient¿s thigh, when pulling the safety needle from the device the needle came out of the safety device leaving the guide wire and needle exposed and separate from the plastic shielding.There was no report of injury or medical interventions.
|
|
Manufacturer Narrative
|
Based on dhr review for material 383318 with lot number 7004946, the product lot met the manufacturing specifications and qa inspections.Without defective sample or photo and with the provided information per the customer for us is very difficult to determinate the root of cause, by this reason we were not able to associate the reported defect to the mfg.Process.It¿s important to mention that this defect is not common in our process.P-eura rm5942 show the procedures used to assemble this product.We currently have the adequate controls to detect any problems of activation or exposed needle during assembly of this product.No capa necessary.
|
|
Search Alerts/Recalls
|