Model Number SYR, NPD 0.3CC 31G 100CT5/16" 8/CS |
Device Problems
Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979)
|
Patient Problem
Pain (1994)
|
Event Date 12/03/2021 |
Event Type
malfunction
|
Event Description
|
Consumer reported complaint for the trueplus single-use insulin syringes.Complaint was initially reported via e-mail and customer was contacted via telephone.Doctor is calling on behalf of facility.Doctor is using the syringes outside of the product's intended use of insulin administration; doctor stated that he is using the insulin syringes to inject botox into his patients.Doctor stated that the needles on the syringes were dull or had a "barb" at the end; doctor stated patients were informing the staff that the syringes were causing pain.Doctor stated he had attempted to return syringes to the pharmacy where purchased and they had referred him to the manufacturer.Doctor stated he has (b)(4) boxes, (b)(4) each, of the 31g syringes, lot number np21023.Doctor declined returning to pharmacy for replacement.
|
|
Manufacturer Narrative
|
(b)(4).Syringes were not returned for evaluation.Note 1: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
|
|
Manufacturer Narrative
|
Sections with additional information as of 16-mar-2022: h6: updated fda¿s type, findings and conclusions codes.H10: syringes were not returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer.Reported defect not reproduced on retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.
|
|
Search Alerts/Recalls
|