KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP 54IN X 54IN
Received Jul 7, 2026 · Event occurred Jun 9, 2026
Report 1054380-2026-00009 · MDR key 25734283
Device
Generic name
Sterilization Products
Manufacturer
O&m Halyard, Inc.Model number
34142Catalog number
34142
Lot number
LT5079000
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE HOSPITAL REPORTED DEFECTS IN THE WRAP CHARACTERIZED BY LIGHTER AREAS VISIBLE WHEN HELD UP TO LIGHT. IT IS UNCLEAR WHETHER THE ISSUE IS DUE TO DISCOLORATION OR MATERIAL DEGRADATION, SUCH AS HOLE FORMATION. THE HOSPITAL EVALUATED THREE TRAYS BEFORE IDENTIFYING ONE THAT WAS UNAFFECTED. THIS RESULTED IN A 30-MINUTE DELAY IN THE PROCEDURE. NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
THE SAMPLE IS SAID TO BE AVAILABLE FOR EVALUATION BUT NOT RECEIVED YET. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(6). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.