Catalog Number 309648 |
Device Problem
Difficult to Advance (2920)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/13/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7215974; medical device expiration date: 07/31/2022; device manufacture date: 08/03/2017.Medical device lot #: 7178678; medical device expiration date: 09/30/2022; device manufacture date: 06/27/2017.(b)(6).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 there was difficult plunger movement found while using a bd¿ syringe luer-lok¿.There was no report of exposure, serious injury or medical intervention.
|
|
Manufacturer Narrative
|
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 manufacturer: yes.
|
|
Event Description
|
It was reported there was difficult plunger movement found while using a bd syringe luer-lok.There was no report of exposure, serious injury or medical intervention.
|
|
Manufacturer Narrative
|
H.6.Investigation summary: one sample of 1ml ll syringe without package and lot number was received.The plunger rod of the sample was found to be detached from stopper.Device history record review showed no rejected inspections or quality issues during the production of the two provided lot number that could have contributed to the reported defect.Investigation conclusion: the root cause of the product defect identified ¿plunger rod detached from stopper¿ is associated with the assembly process.
|
|
Event Description
|
It was reported there was difficult plunger movement found while using a bd¿ syringe luer-lok¿.There was no report of exposure, serious injury or medical intervention.
|
|
Search Alerts/Recalls
|