Catalog Number 031-33J |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/20/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
|
|
Event Description
|
It was reported that the user found a volume of water pooled in the corrugated tube and the water trap during use on a patient.Therefore, the adaptor was replaced with a new one.No patient harm was reported.
|
|
Manufacturer Narrative
|
(b)(4).One unit of 031-33j "nebulizer adaptor 033,sterile,japanese" was received for analysis.Signs of use were observed since the sample was not received in its original package.A visual exam was performed and it was observed that the puncture pin was missing.No other issues were found.The missing component was assembled on to the sample and functional testing was performed.No issues were encountered.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The unit functioned as intended.
|
|
Event Description
|
It was reported that the user found a volume of water pooled in the corrugated tube and the water trap during use on a patient.Therefore, the adaptor was replaced with a new one.No patient harm was reported.
|
|
Search Alerts/Recalls
|