Model Number 328468 |
Device Problem
Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/09/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0279502.Medical device expiration date: 2025-10-31.Device manufacture date: 2020-10-05.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
|
|
Event Description
|
It was reported that an unspecified number of syringe 0.5ml 31ga 8mm ufii 10bag 500cs had the shield difficult to detach during use.The following was reported by the initial reporter: "it was reported that needle shields are difficult to remove.Verbatim: consumer reported found 2 syringes cannot remove the needle shield.Placed to the side for mailing kit.Lot #: 0279502.Catalog#: 328468.Date of event: unknown - within the past month.Sample status: awaiting sample.Consumer reported found in all prior boxes 1 out of 10 syringes, needle shields hard to remove.Lot #: unknown.Catalog#: 328468.Date of event: unknown.Sample status: discard.
|
|
Event Description
|
It was reported that an unspecified number of syringe 0.5ml 31ga 8mm ufii 10bag 500cs had the shield difficult to detach during use.The following was reported by the initial reporter: "it was reported that needle shields are difficult to remove.Verbatim: consumer reported found 2 syringes cannot remove the needle shield.Placed to the side for mailing kit.Lot # 0279502.Catalog# 328468.Date of event unknown - within the past month.Sample status awaiting sample.Consumer reported found in all prior boxes 1 out of 10 syringes, needle shields hard to remove.Lot # unknown.Catalog# 328468.Date of event unknown.Sample status discard.
|
|
Manufacturer Narrative
|
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 0279502.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.A device history review could not be completed on the unknown batch number.
|
|
Search Alerts/Recalls
|