Catalog Number 320559 |
Device Problem
Complete Blockage (1094)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/09/2022 |
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 3 bd micro-fine¿+ pro pen needles were clogged and had no medication flow during the priming process.The following information was provided by the initial reporter, translated from japanese: "this is a report about needle clog.According to the user's report, the drug solution did not come out upon priming in a few products.".
|
|
Manufacturer Narrative
|
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.No dhr review can be carried out as lot number is unknown.
|
|
Event Description
|
It was reported that 3 bd micro-fine¿+ pro pen needles were clogged and had no medication flow during the priming process.The following information was provided by the initial reporter, translated from japanese: "this is a report about needle clog.According to the user's report, the drug solution did not come out upon priming in a few products.".
|
|
Search Alerts/Recalls
|