STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD & SKIN PREP
Received Jun 23, 2021 · Event occurred Jun 1, 2021
Report 3006260740-2021-02420 · MDR key 12050725
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
VPPCSPCE
Lot number
JUEZ0865
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 JUEZ0865 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(4).
Description of Event or Problem
IT WAS REPORTED THE PROBLEM ENCOUNTERED BY THE NURSE: WHEN OPENING THE DRESSING OF THE HICKMANN CATHETER, OPEN FIN - CHANGE OF STATLOCK AND SAME PROBLEM DURING FITTING: THE FIN DOES NOT CLOSE ON THE CATHETER CONSEQUENCE, THE CATHETER MOVES. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.