STERILE ROBOTIC/LAPAROSCOPY KITTNER ROLLS MEDIUM 4" LONG 5PK 25PKS
Received Jul 14, 2025 · Event occurred Sep 27, 2021
Report 2951379-2021-00004 · MDR key 22503004
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Carefree Surgical Specialties, Inc.Model number
15505/25Lot number
1440
Product problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CUSTOMER REPORTED INCORRECT QUANTITY IN SKU 15505/25, LOT 1440. PACKAGE LABELED AS 5-PACK CONTAINED 6 UNITS. THE PRODUCT WAS NOT USED, AND NO PATIENT CONTACT OCCURED. ROOT CAUSE DETERMINED TO BE OPERATOR OVERSIGHT DURING FINAL PACKAGING. STAFF WAS RETRAINED AND ADDITIONAL PACKAGING CHECKS IMPLEMENTED. DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem
OPERATING ROOM REPORTS PICKING A CASE AND PULLED ROBOTIC KITTNER ROLLS. THEY ARE SUPPOSED TO HAVE 5 PER PACK. NURSE FOUND 2 PACKS WITH ONLY 4 SEALED INSIDE AND ONE PACK WITH 6. RN PULLED THEM FROM THE OMNICELL. THIS WAS DISCOVERED PRIOR TO REACHING THE PATIENT.
Remedial action
- Replace