HVE (HIGH VOLUME EVACUATOR) TIPS
Received Dec 1, 2023 · Event occurred Nov 2, 2023
Report 1319130-2023-00014 · MDR key 18247340
Device
Generic name
Slotted Evacuator Tips
Manufacturer
Spsmedical Supply Corp. A Div. Of Crosstex Intl.Model number
22357410Lot number
22740091 & 20908322
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
CROSSTEX HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE REPORTED EVENT. TO DATE, WE HAVE NOT RECEIVED A RESPONSE. AS NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT, A ROOT CAUSE COULD NOT BE DETERMINED. CROSSTEX WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Additional Manufacturer Narrative
INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR SLOTTED EVACUATOR TIPS ARE ABRASIVE AND CUTTING PATIENT'S LIPS. IT IS UNKNOWN IF THE PATIENT'S RECEIVED MEDICAL TREATMENT.