SEQUENTIAL H300 STERILIZATION WRAP 40 IN X 40 IN
Received Jun 25, 2026
Report 1054380-2026-00007 · MDR key 25621987
Device
Generic name
Sterilization Products
Manufacturer
O&m Halyard, Inc.Model number
10840Catalog number
10840
Lot number
LN5064000
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. 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 (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, 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.
Description of Event or Problem
RECENTLY, WE HAVE BEEN RECEIVING A LARGE NUMBER OF STERILIZATION PACKAGES RETURNING FROM THE OPERATING ROOM WITH HOLES WHEN USING HALYARD SHEETS. THE CUSTOMER REPORTED A SIGNIFICANT NUMBER OF WRAPS RETURNING FROM THE OPERATING ROOM WITH HOLES. THE CUSTOMER EXPLAINED THAT THEY HAVE BEEN UNABLE TO IDENTIFY THE CAUSE OF THE HOLES DUE TO THE WIDE VARIATION IN HOLE TYPES, THE DIFFERENT EQUIPMENT INVOLVED, AND THE MULTIPLE STERILIZATION PROCESSES USED. THE SCHEDULED PROCEDURE WAS CANCELLED.