Catalog Number 9200229 |
Device Problem
Contamination /Decontamination Problem (2895)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
This report has been identified as event 1 of b.Braun medical internal report number (b)(4).The device involved has been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.Although the exact lot number is unknown, two (2) potential batch numbers were provided: 18l08c0 (production date: 10/08/2018; expiration date: 04/01/2024), 18c19c0 (production date: 03/19/2018; expiration date: 09/01/2023).
|
|
Event Description
|
Event 1: as reported by the user facility: a white lengthy string forming a ring around the inside of a syringe was observed.As the plunger of the syringe was moved, the material was pushed into the side of the plunger.
|
|
Manufacturer Narrative
|
This report has been identified as event 1 of b.Braun medical internal report number (b)(4).One (1) sample was returned for evaluation.Per inspection of the returned sample, white circular sediments were detected after moving the plunger.A small inclusion (less than 0.5mm²) was also found in the cylinder material.This inclusion was found to be within specification.The white sediment material was tested and found to be migrated lubricant (slip additive) from the syringe barrel.This lubricant is used to ensure the gliding of the syringe plungers.The used amount of lubricant is approximately a quarter of the normative defined maximal amount.Therefore, an excess of the inner lubricant can be excluded.During the production process, 3 operator self-inspections and 1 in-process-control inspection are performed each shift to inspect for contaminations.The migration process of the lubricant can be a result of storage temperature in connection to the storage time.If additional pertinent information becomes available a follow-up report will be filed.
|
|
Search Alerts/Recalls
|