Catalog Number 326725 |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/23/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported while using bd ultra-fine¿ ii short needle insulin syringe foreign matter compromised sterility.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: i bought a total of 5x boxes of needles in shopee thailand (bd ultra-fine ii short needle 0.5 ml 100 's 30gx8mm) and i got dirty needles.I have no idea how you can reach out to this seller, but they should stop selling dirty needles because this is a serious matter.I always bought those needles and only these batches, i also ordered from different suppliers/sellers but they look the same, so i guess your company has a problem with it.This is the photo you can see inside it has moist in it.I notice that even i order from other sellee are the same.And i dont know what's inside.It's all contaminated.
|
|
Event Description
|
It was reported while using bd ultra-fine¿ ii short needle insulin syringe foreign matter compromised sterility.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: i bought a total of 5x boxes of needles in shopee thailand (bd ultra-fine ii short needle 0.5 ml 100 's 30gx8mm) and i got dirty needles.I have no idea how you can reach out to this seller, but they should stop selling dirty needles because this is a serious matter.I always bought those needles and only these batches, i also ordered from different suppliers/sellers but they look the same, so i guess your company has a problem with it.This is the photo you can see inside it has moist in it.I notice that even i order from other sellee are the same.And i dont know what's inside.It's all contaminated.
|
|
Manufacturer Narrative
|
H6: investigation summary no samples were returned therefore the investigation is performed based on the photos provided.The customer provided (4) photos of 0.5ccm 30ga 8mm syringe, reporting foreign matter.The photos were visually examined, and no issues were observed.Based on the photos provided, embecta was not able to confirm the reported failure.Due to the batch being unknown, no dhr review can be completed.
|
|
Search Alerts/Recalls
|