CAREFREE KITTNER ROLL W/ TAIL LONG 4" LONG 5PK 25PKS/CS
Received Jul 14, 2025 · Event occurred Jun 7, 2021
Report 2951379-2021-00001 · MDR key 22503005
Device
Generic name
Sterile Kittner Roll
Manufacturer
Carefree Surgical Specialties, Inc.Model number
15508/25Lot number
1338
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 15508/25, LOT 1338. PACKAGE LABELED AS 5PK CONTAINED 6 UNITS. THE PRODUCT WAS NOT USED, AND NO PATIENT CONTACT OCCURRED. ROOT CAUSE DETERMINED TO BE OPERATOR OVERSIGHT DURING FINAL PACKAGING. STAFF WAS RETRAINED AND ADDITIONAL PACKAGING CHECKS IMPLEMENTED. A REPLACEMENT PRODUCT WAS SENT. DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem
CUSTOMER REPORTED THERE IS NO CARDBOARD BACKING. THEY ARE INDIVIDUALLY PLACED IN THE PACKAGE. THIS PACKAGE HAS 6 ROLLS INSTEAD OF 5 KITTNER ROLLS IN A 5PK.
Remedial action
- Replace