STATLOCK PICC PLUS CRESCENT SLIDING POST
Received May 13, 2021 · Event occurred Mar 8, 2021
Report 3006260740-2021-01845 · MDR key 11822636
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
PIC0220
Lot number
JUEW3276
Product problems
- Misconnection
- Misconnection
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEW3276 SHOWED TWO SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED CLIPS THAT SECURE CATHETER IN PLACE ARE COMING UNCLIPPED. ADDITIONAL INFO RECEIVED (B)(6) 2021 "THERE WAS NO PATIENT HARM WITH ANY OF THE COMPLAINTS." THE PLACEMENT WAS EXACTLY THE SAME FOR ALL PATIENTS. THE MOVEABLE POSTS WERE INSERTED IN THE WINGS AND THE STAT LOCK WAS APPLIED TO THE CHEST AREA, BELOW THE EXIT SITE OF THE CATHETER. THIS STAT LOCK HAS BEEN USED FOR YEARS IN THIS WAY AND NEVER HAVE THE GATES POPPED OPEN AS THEY DO NOW. NURSES HAVE TAKEN TO TAPING OVED THE GATES TO KEEP IT SECURE. I STILL DON¿T HAVE A SAMPLE OF THE AFFECTED PRODUCT TO SEND YOU.