GHIATAS

Description of Event or Problem

IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT, THERE WAS NO SPECIFICATION ON THE PACKAGING REFERRING TO MRI. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. 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. HOWEVER, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED IMPROPER OR INCORRECT PROCEDURE OR METHOD AS AN USER ISSUE WAS IDENTIFIED. AN USER ISSUE MAY HAVE CONTRIBUTED TO THE REPORTED ARTIFACT, HOWEVER, A DEFINITIVE ROOT CAUSE FOR THE REPORTED IMAGE DISPLAY ERROR /ARTIFACT COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF THE BD GHIATAS BEADED BREAST LOCALIZATION WIRE INSTRUCTIONS FOR USE DETERMINED THE PRODUCT LABELING DOCUMENTATION IS ADEQUATE. PER THE GHIATAS BEADED BREAST LOCALIZATION WIRE INSTRUCTIONS FOR USE (IFU), PRODUCT CODES WITH 475201, 477201, 479201, AND 470201 MAY BE PLACED UNDER MRI GUIDANCE AS THE REPORTED PRODUCT CODE 47920 WAS NOT SUPPOSED TO BE OPERATED UNDER MRI. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Additional Manufacturer Narrative

H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT, THERE WAS NO SPECIFICATION ON THE PACKAGING REFERRING TO MRI. THERE WAS NO REPORTED PATIENT INJURY.