STATLOCK PICC PLUS CRESCENT SLIDING POST
Received May 12, 2021 · Event occurred Apr 13, 2021
Report 3006260740-2021-01819 · MDR key 11814178
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
PIC0220
Lot number
JUEX1695
Product problems
- Misconnection
- Misconnection
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEX1695 SHOWED THREE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT THE CLIPS THAT SECURE CATHETER IN PLACE ARE COMING UNCLIPPED. ADDITIONAL INFORMATION RECEIVED 04/26/2021 "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 STATLOCK WAS APPLIED TO THE CHEST AREA, BELOW THE EXIT SITE OF THE CATHETER. THIS STATLOCK 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."