Catalog Number 309657 |
Device Problem
Retraction Problem (1536)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/30/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Without the lot#, the manufacturing location for this product is unknown.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.The device carries two 510k #s, that we are unable to determine which site it was manufactured at without the lot #.510k # for this device are: k151766 and k980987.Medical device expiration date: unknown.Device manufacture date: unknown.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 that a customer attempt to draw back on a bd¿ syringe ll s/c to fill with air, but when customer released the plunger, plunger would retract by itself and push all the air out.This event happened four times.Customer¿s verbatim: ¿ customer attempted to draw back on syringe to fill with air.When customer released plunger, plunger would retract pushing all the air out.¿.
|
|
Event Description
|
It was reported that a customer attempt to draw back on a bd¿ syringe ll s/c to fill with air, but when customer released the plunger, plunger would retract by itself and push all the air out.This event happened four times.Customer¿s verbatim: ¿ customer attempted to draw back on syringe to fill with air.When customer released plunger, plunger would retract pushing all the air out.¿.
|
|
Manufacturer Narrative
|
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.
|
|
Search Alerts/Recalls
|