Catalog Number 300483 |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
Needle Stick/Puncture (2462)
|
Event Date 10/27/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Pma / 510(k) #: there is no 510(k) # for this device as it is marketed outside the us.A sample is not available, however the customer has provided photos of the device in question.A photo evaluation and device history record review will be completed as part of a no sample investigation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
|
|
Event Description
|
It was reported that a needle pierced through a 22.7 l bd" nestable sharps collector and an employee was stuck with a contaminated needle from an unknown source patient.The needle stick injury occurred after the employee had picked up the container from an autoclave.The employee received post exposure lab work and the test results were negative.
|
|
Manufacturer Narrative
|
Results: a sample is not available for evaluation, however the customer provided photos of the device in question.A photo inspection revealed that a needle had penetrated the wall of the sharps collector.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5261930.Conclusion: although the photos confirmed the customer's indicated failure mode, without a sample, an absolute root cause for this incident cannot be determined as the device history record indicates that the product meets all attribute and variable characteristics.
|
|
Search Alerts/Recalls
|