inforMED
MalfunctionGDZ

SCALPEL HOLDER RED, ASPEN LEAF WITH BARD-PARKER, SERILE (100/BOX)

Received Sep 28, 2023 · Event occurred Sep 1, 2023

Report 1836161-2023-00032 · MDR key 17835928

Device

Generic name

Handle, Scalpel

Model number

ST-100

Lot number

335954

Product problems

  • Unsealed Device Packaging
  • Unsealed Device Packaging

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. PHOTOGRAPHIC EVIDENCE WAS PROVIDED FOR REVIEW AS WELL. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A SCALPEL HOLDER WAS DISCOVERED WITH A SEALING ISSUE. THE ITEM WAS NOT IN USE. NO INJURY/DEATH WAS REPORTED. THIS EVENT WAS FILED IN OUR COMPLIANT HANDLING SYSTEM AS NUMBER (B)(4).