Model Number 305060 |
Device Problems
Break (1069); Leak/Splash (1354)
|
Patient Problem
No Information (3190)
|
Event Date 08/10/2020 |
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.(b)(4).
|
|
Event Description
|
It was reported that an unspecified number of syringe 3ml ll w/ndl 18x1-1/2 blunt fill experienced device damage/deformation.It has not been specified whether the product defect was noted prior to, during, or after use.The following information was provided by the initial reporter: event description: 3ml syringe taken out of a sealed package and found a hole in the syringe.The hole is at the end of the 3ml marking on the syringe.
|
|
Event Description
|
It was reported that an unspecified number of syringe 3ml ll w/ndl 18x1-1/2 blunt fill experienced device damage/deformation.It has not been specified whether the product defect was noted prior to, during, or after use.The following information was provided by the initial reporter: event description: 3ml syringe taken out of a sealed package and found a hole in the syringe.The hole is at the end of the 3ml marking on the syringe.
|
|
Manufacturer Narrative
|
H.6.Investigation: since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident and a potential root cause could not be defined.For batch 0057522, all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.The batch was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Since no samples displaying the reported condition were received corrective actions are not necessary.
|
|
Search Alerts/Recalls
|