Catalog Number 323487 |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/17/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The manufacturing location for this product is premium plastic solution.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.D.4 device expiration date: na.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that the bd¿ home sharps container, 1.4 quart lid was difficult to operate.The following information was provided by the initial reporter: consumer reported hard time closing the lid to container.This caller has neuropathy and not a lot of strength.This container does not have sharps in it as of yet.Informed caller to place lid onto container only when full.
|
|
Event Description
|
It was reported that the bd¿ home sharps container, 1.4 quart lid was difficult to operate.The following information was provided by the initial reporter: consumer reported hard time closing the lid to container.This caller has neuropathy and not a lot of strength.This container does not have sharps in it as of yet.Informed caller to place lid onto container only when full.
|
|
Manufacturer Narrative
|
H.6.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.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
|
|
Search Alerts/Recalls
|