Catalog Number 309628 |
Device Problem
Detachment Of Device Component (1104)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/24/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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 that rubber plunger of the bd luer-lok¿ disposable syringe, detaches from the white plunger rod.
Staff reports being able to sometimes push the plunger back in to start over.
Found during use.
No reports of serious injury or medical intervention noted.
|
|
Event Description
|
It was reported that rubber plunger of the bd luer-lok¿ disposable syringe, detaches from the white plunger rod.
Staff reports being able to sometimes push the plunger back in to start over.
Found during use.
No reports of serious injury or medical intervention noted.
|
|
Manufacturer Narrative
|
Investigation summary: one 1ml ll syringe inside an opened package was received taped to piece of paper.
The sample was confirmed to be from batch #7235566 (p/n 309628).
It was evaluated.
No visual defects were observed.
The plunger had the stopper attached and was at the bottom out position.
The plunger was pulled back until the break out occurred ¿ the stopper remained attached to the plunger rod.
The plunger was exercised to the 1ml marking and back down to zero.
No defects were found in the sample received.
No root cause or corrective actions can be determined as no defects were confirmed.
Also, this is the 1st related complaint for stopper seperation from plunger on the provided lot number 7235566.
Moreoever, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Investigation conclusion: the reported defect was not identified in the samples received.
Unable to determine a root cause.
|
|
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 field: device returned to manufacture: yes.
|
|
Event Description
|
It was reported that rubber plunger of the bd luer-lok disposable syringe, detaches from the white plunger rod.
Staff reports being able to sometimes push the plunger back in to start over.
Found during use.
No reports of serious injury or medical intervention noted.
|
|
Search Alerts/Recalls
|