Catalog Number 368653 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 06/12/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter phone #: (b)(6).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 there was a hole in the tubing of bd vacutainer® safety-lok¿ blood collection set and blood seeped out.No report of injury or medical intervention.No report of blood exposure to mucous membrane.
|
|
Event Description
|
It was reported that there was a hole in the tubing of bd vacutainer® safety-lok¿ blood collection set and blood seeped out.No report of injury or medical intervention.No report of blood exposure to mucous membrane.
|
|
Manufacturer Narrative
|
Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: unknown, event attributed to: other, device single use?: no, device returned to manufacture: no.
|
|
Manufacturer Narrative
|
Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
|
|
Event Description
|
It was reported that there was a hole in the tubing of bd vacutainer® safety-lok¿ blood collection set and blood seeped out.No report of injury or medical intervention.No report of blood exposure to mucous membrane.
|
|
Search Alerts/Recalls
|