GHIATAS

Additional Manufacturer Narrative

: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED NEEDLE BREAK COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. (EXPIRY DATE: 10/2023).

Description of Event or Problem

IT WAS REPORTED THAT DURING THE BREAST LOCALIZATION WIRE PLACEMENT, THE PUNCTURE NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.