Catalog Number 301027 |
Device Problems
Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/24/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that before use of the bd plastic non-sterile luer-lok¿ tip syringe, it had pieces of the plunger broken off.There was no report of exposure, serious injury or medical intervention.
|
|
Event Description
|
It was reported that before use of the bd plastic non-sterile luer-lok tip syringe, it had pieces of the plunger broken off.There was no report of exposure, serious injury or medical intervention.
|
|
Manufacturer Narrative
|
Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.
|
|
Search Alerts/Recalls
|