Model Number 300912 |
Device Problems
Break (1069); Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/06/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.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 two syringe 10ml ll eurographics were damaged had leakage issues.The following information was provided by the initial reporter, translated from (b)(6): "on the 10ml syringe, we had a large crack on two syringes this week.This caused leakage.".
|
|
Manufacturer Narrative
|
H.6.Investigation: two photos, an opened blisterpak from batch #1082907, and a loose 10ml syringe (p/n 300912) were received.The sample was visually evaluated.The syringe was observed to have a large crack outside of the print area extending from the 1ml grad line down to the 9ml grad line.The damage observed was non-conforming per product specification.Potential root cause for the cracked barrel defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1082907 is considered in compliance with our product specification requirements.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.H3 other text : see h.10.
|
|
Event Description
|
It was reported two syringe 10ml ll eurographics were damaged had leakage issues.The following information was provided by the initial reporter, translated from dutch: "on the 10ml syringe, we had a large crack on two syringes this week.This caused leakage.".
|
|
Search Alerts/Recalls
|