TAUT INTRADUCERS 10/BX7.5 FR X 3.5
Received Jun 7, 2017 · Event occurred May 17, 2017
Report 3003898360-2017-00660 · MDR key 6619726
Device
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT TAUT INTRADUCERS 10/BX7.5 FR X 3.5, LOT #73K1600792 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
UPON USE OF INTRADUCER, DURING INSERTION OF THE CATHETER, THE VERY SMALL, CLEAR DISC ON TOP OF INTRADUCER OR SEAL FELL INTO THE PATIENT. THE CUSTOMER STATED THAT THEY MAY BE HITTING THE DISC WITH THE EDGE OF THE CATHETER AND PUSHING IT THROUGH BUT THAT IT HAS HAPPENED ON THREE SEPARATE OCCASIONS WITH THREE DIFFERENT LOT NUMBERS. NO PATIENT INJURY OR NEED TO RETURN FOR TREATMENT, THE PHYSICIAN IS SIMPLY REMOVING THE PIECE THEN AND THERE.