BARD-PARKER SAFETY SCALPEL SIZE 15, STERILE
Received May 14, 2026
Report 3002750084-2026-00045 · MDR key 25173307
Device
Generic name
Safety Scalpel
Manufacturer
Aspen Surgical Products, Inc.Model number
372615Lot number
0506984
Product problems
- Unsealed Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR EVALUATION. THE ROOT CAUSE WAS MANUFACTURING ERROR. THE MOST PROBABLE ROOT CAUSE IS ATTRIBUTED TO OPERATOR ERROR. AFTER LEAK AND BURST TESTING PROCESS, THE OPERATOR IS RESPONSIBLE FOR REMOVING ALL TESTED SAMPLES AND ENSURING THEY ARE PROPERLY SENT TO THE REPACKAGING PROCESS. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
COMPLAINANT ALLEGES "TODAY WE RECEIVED A BOX OF 372615 THAT IS DAMAGED. EACH BLADE HAS A STICKY SPOT WITH A HOLE IN THE PACKAGE AND SOME ARE NOT SEALED."