COMBO-TIP EVACUATOR
Received Oct 24, 2018 · Event occurred Jun 4, 2018
Report 3006008984-2018-00001 · MDR key 8003381
Device
Generic name
Oral Cavity Evacuator
Manufacturer
Crosstex International Inc.Model number
ZETLot number
08/31/171, 08/18/171, 04/19/17
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
THE FACILITY REPORTED THAT WHILE USING A CROSSTEX COMBO-TIP EVACUATOR, SHARDS OF PLASTIC PROTRUDING FROM THE TIP CAUSED THE PATIENT TO BLEED. THE CUSTOMER DID NOT RETURN THE PRODUCT FOR CROSSTEX QUALITY INVESTIGATION. LIMITED INFORMATION RELATED TO THIS COMPLAINT AND THE EXTENT OF THE REPORTED INJURIES WAS PROVIDED. THE PRODUCT WAS REPLACED WITH ANOTHER COMBO-TIP EVACUATOR. CROSSTEX HAS NOT RECEIVED ANY COMPLAINTS SIMILAR TO THIS EVENT. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE CROSSTEX COMPLAINT HANDLING SYSTEM.
Description of Event or Problem
THE FACILITY REPORTED THAT WHILE USING A CROSSTEX COMBO-TIP EVACUATOR, SHARDS OF PLASTIC PROTRUDING FROM THE TIP CAUSED THE PATIENT TO BLEED.