inforMED
MalfunctionGDZ

SCALPEL HOLDER RED, BARD-PARKER, STERILE

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

Report 1836161-2023-00044 · MDR key 18220678

Device

Generic name

Handle, Scalpel

Model number

ST-100

Lot number

348492, 353311

Product problems

  • Unsealed Device Packaging
  • Unsealed Device Packaging

Patient

Unknown

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

Narrative

Description of Event or Problem

ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT TWO SCALPEL HOLDERS WERE DISCOVERED WITH SEALING ISSUES. THE ITEMS WERE NOT IN USE. NO INJURY/DEATH WAS REPORTED. CUSTOMER REPORTED THE ISSUE FOR MULTIPLE LOT NUMBERS. LOT NUMBER AND RESPECTIVE COMPLAINT NUMBERS ARE AS FOLLOWS: C-1183308 (LOT 348492), C-1183310 (LOT 353311).

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. H3 OTHER TEXT : DEVICE NOT AVAILABLE.