Model Number SYR, KGR 1.0CC 29G 100CT1/2" 8/CS |
Device Problems
Dull, Blunt (2407); Material Twisted/Bent (2981)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/18/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on 21-nov-2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated she had attempted to return syringes to pharmacy.Customer stated the pharmacy tried three of the syringes and that they did not pierce the skin.Customer did not have pharmacy receipt; refund requested.Note 2: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
|
|
Event Description
|
Consumer reported complaint for the trueplus single-use insulin syringes.Fiancé is calling on behalf of the customer.Customer stated that the syringes are not sharp and they do not puncture the skin.Customer also stated that the needle is not straight.The package had not been open or damaged when received ty the customer.This was the first time the customer has used the product out of this package.Customer had attempted to return syringes to pharmacy and was told to contact manufacturer for refund.The customer feels well and did not report any symptoms.The customer did not claim to be injured using the syringes and no medical attention associated with the use of the product was reported.
|
|
Manufacturer Narrative
|
Sections with additional information as of 11-jan-2023: 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 using syringes from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.
|
|
Search Alerts/Recalls
|