Model Number 381834 |
Device Problem
Device Markings/Labelling Problem (2911)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/10/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 when using the bd insyte¿ autoguard¿ shielded iv catheter there was mix of product types in a pack.The following information was provided by the initial reporter.The customer stated: "during an in-process control in production the operator checked the catheter batch number which should normally been 1074200 (supplier's batch) but which was in fact 1070995.".
|
|
Event Description
|
It was reported when using the bd insyte¿ autoguard¿ shielded iv catheter there was mix of product types in a pack.The following information was provided by the initial reporter.The customer stated: "during an in-process control in production the operator checked the catheter batch number which should normally been 1074200 (supplier's batch) but which was in fact 1070995.".
|
|
Manufacturer Narrative
|
H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.
|
|
Search Alerts/Recalls
|