Model Number 10602 |
Device Problem
Device Markings/Labelling Problem (2911)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/01/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.
|
|
Event Description
|
It was reported that incorrect content of the package was encountered.A 2.5 x 16 synergy drug-eluting stent was selected for use; however, when the box was opened, a 2.50 x 20 synergy drug-eluting stent was inside the box.The device was not used inside the patient.
|
|
Event Description
|
It was reported that incorrect content of the package was encountered.A 2.5 x 16 synergy drug-eluting stent was selected for use; however, when the box was opened, a 2.50 x 20 synergy drug-eluting stent was inside the box.The device was not used inside the patient.
|
|
Manufacturer Narrative
|
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: a boston scientific outer packaging box was received with the blue tab seal broken and the box open.The box was labelled with the following information: synergy monorail 2.50 x 16 mm, lot 22595298 and upn h7493926016250.Inside the box there was a sealed unopened foil pouch (pouch does not match box details), per foil pouch labelling: synergy monorail 2.50 x 20 mm, lot 22595748, upn h7493926020250.No issues were noted with pouch, all labelling was legible.
|
|
Search Alerts/Recalls
|